The Design Quality Engineer will assist in regulatory filings for Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party ...

49 Avalign Technologies Jobs Hiring Near You
The Design Quality Engineer will assist in regulatory filings for Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party ...
Hiring Event for CNC Machinists - Wednesday, June 24th
Fort Wayne, IN · On-site
$25 - $35/hr
Avalign Technologies is holding a hiring event for full-time CNC Machine Operators and Machinists! We're located at 8415 Clinton Park Drive, Fort Wayne, IN 46825. Come by on **Wednesday, June 24th 2 ...
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Hiring Event for CNC Machinists - Wednesday, June 24th
Fort Wayne, IN · On-site
$25 - $35/hr
Avalign Technologies is holding a hiring event for full-time CNC Machine Operators and Machinists! We're located at 8415 Clinton Park Drive, Fort Wayne, IN 46825. Come by on **Wednesday, June 24th 2 ...
Swiss CNC Lathe Machinist -- Medical Device Components
Fort Wayne, IN · On-site
$25 - $35/hr
That's a typical day with Avalign Technologies--where precision fuels patient outcomes. Walk-In Hiring Event (On-the-Spot Interviews) When: Wednesday, June 24th, 2:00 pm - 6:00 pm Where: 8415 Clinton ...
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Swiss CNC Lathe Machinist -- Medical Device Components
Fort Wayne, IN · On-site
$25 - $35/hr
That's a typical day with Avalign Technologies--where precision fuels patient outcomes. Walk-In Hiring Event (On-the-Spot Interviews) When: Wednesday, June 24th, 2:00 pm - 6:00 pm Where: 8415 Clinton ...
Customer Service Rep
Fort Wayne, IN · On-site
$14.75 - $20/hr
Customer Service Representative Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and ...
Customer Service Rep
Fort Wayne, IN · On-site
$14.75 - $20/hr
Customer Service Representative Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and ...
Accounts Payable/ Receivable Analyst
Schaumburg, IL · On-site
$23.50 - $30/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Accounts Payable/ Receivable Analyst
Schaumburg, IL · On-site
$23.50 - $30/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Customer Service Rep
Greenwood, IN · On-site
$14.50 - $19.75/hr
Customer Service Representative Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and ...
Customer Service Rep
Greenwood, IN · On-site
$14.50 - $19.75/hr
Customer Service Representative Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and ...
CNC Swiss Lathe Machinist - 2nd Shift
Fort Wayne, IN · On-site
$20.25 - $27.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CNC Swiss Lathe Machinist - 2nd Shift
Fort Wayne, IN · On-site
$20.25 - $27.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CNC Lathe Machinist - 1st Shift
Akron, OH · On-site
$21 - $26.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CNC Lathe Machinist - 1st Shift
Akron, OH · On-site
$21 - $26.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CNC Swiss Lathe Machinist - Weekend Shift
Fort Wayne, IN · On-site
$20.25 - $27.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CNC Swiss Lathe Machinist - Weekend Shift
Fort Wayne, IN · On-site
$20.25 - $27.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Customer Service Rep
Greenwood, IN · On-site
$15.25 - $20.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Customer Service Rep
Greenwood, IN · On-site
$15.25 - $20.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CMM Operator - 3rd shift
Portland, OR · On-site
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CMM Operator - 3rd shift
Portland, OR · On-site
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CNC Mill Machinist - 3rd Shift
Warsaw, IN · On-site
$21.25 - $28.25/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CNC Mill Machinist - 3rd Shift
Warsaw, IN · On-site
$21.25 - $28.25/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Engineering Technician
Warsaw, IN · On-site
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Engineering Technician
Warsaw, IN · On-site
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Mill Machinist Lead
Greenwood, IN · On-site
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Mill Machinist Lead
Greenwood, IN · On-site
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Sr. Financial Analyst
Mentor, OH · On-site
$76K - $95K/yr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Sr. Financial Analyst
Mentor, OH · On-site
$76K - $95K/yr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CNC Lathe Operator - 2nd Shift
Mentor, OH · On-site
$19.75 - $25/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CNC Lathe Operator - 2nd Shift
Mentor, OH · On-site
$19.75 - $25/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Straightener Operator - 2nd or 3rd shift
Warsaw, IN · On-site
$16.50 - $19.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Straightener Operator - 2nd or 3rd shift
Warsaw, IN · On-site
$16.50 - $19.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Cleaning Operator - 3rd Shift
Portland, OR · On-site
$18 - $21.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
Cleaning Operator - 3rd Shift
Portland, OR · On-site
$18 - $21.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our ...
CNC Programmer
Fort Wayne, IN · On-site
$26.25 - $35.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular ... Research, test, and implement new cutting tools, work holding, and programming technology. * Ensure ...
CNC Programmer
Fort Wayne, IN · On-site
$26.25 - $35.75/hr
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular ... Research, test, and implement new cutting tools, work holding, and programming technology. * Ensure ...
Avalign Technologies Jobs Information
Do workers at Avalign Technologies get paid breaks?
67% of people say they get paid breaks.
Based on data from 12 people who took the Breakroom Quiz between February 2025 and June 2026.
Does Avalign Technologies pay people when they’re sick?
57% of people say they wouldn’t get paid if they were sick but scheduled to work.
Based on data from 14 people who took the Breakroom Quiz between February 2025 and June 2026.
Is the health insurance from Avalign Technologies affordable enough for their workers?
90% of people say the health insurance costs are okay
Based on data from 10 people who took the Breakroom Quiz between March 2025 and June 2026.
How easy is it to get time off at Avalign Technologies?
85% of people report it’s easy to get time off.
Based on data from 13 people who took the Breakroom Quiz between February 2025 and June 2026.
How easy is it to take sick days at Avalign Technologies?
79% of people report that it’s easy to take time off if they are sick.
Based on data from 14 people who took the Breakroom Quiz between February 2025 and June 2026.
Do people at Avalign Technologies feel treated with respect by their managers?
71% of people say they’re treated with respect by their managers.
Based on data from 14 people who took the Breakroom Quiz between February 2025 and June 2026.
Do people at Avalign Technologies get to take their breaks without interruption?
85% of people report that they get to take their breaks without interruption.
Based on data from 13 people who took the Breakroom Quiz between February 2025 and June 2026.
Is it stressful to work at Avalign Technologies?
69% of people say they often feel stressed out at work.
Based on data from 13 people who took the Breakroom Quiz between March 2025 and June 2026.
Do people at Avalign Technologies enjoy their jobs?
83% of people report they enjoy their job.
Based on data from 12 people who took the Breakroom Quiz between March 2025 and May 2026.
Do people at Avalign Technologies recommend working with their team?
36% of people report that they wouldn’t recommend working with their immediate team to a friend.
Based on data from 14 people who took the Breakroom Quiz between February 2025 and June 2026.
Do people get enough training when they start at Avalign Technologies?
62% of people report they didn’t get enough training when they started working here.
Based on data from 13 people who took the Breakroom Quiz between February 2025 and June 2026.
Do people get support to advance at Avalign Technologies?
In the last year, 71% of people report being given support to advance their career here.
Based on data from 14 people who took the Breakroom Quiz between February 2025 and June 2026.
Do people think Avalign Technologies’s headquarters understands what’s happening where they work?
92% of people think that this employer’s headquarters or owners don’t have a good understanding of what’s really happening where they work.
Based on data from 12 people who took the Breakroom Quiz between February 2025 and June 2026.
Do workers feel well informed about how Avalign Technologies is doing?
82% of people feel that they are kept well informed about how the company is doing as a whole.
Based on data from 11 people who took the Breakroom Quiz between March 2025 and May 2026.

Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 9 days ago
Avalign Technologies rating
8.3
Based on 14 frontline employees who took The Breakroom Quiz
Job description
The Design Quality Engineer will be responsible for the quality and regulatory related activities associated with new product development. New product development activities will occur in the contract development context and in the specification developer context. These activities span all aspects of the new product development process. The Design Quality Engineer will advise customers in the contract development context how to incorporate Critical-To-Quality (CTQ) and Design-For-Inspection (DFI) into the development process. The Design Quality Engineer will provide CTQ and DFI input internally while ensuring that Avalign specification development activities conducted by Research and Development (R&D) comply with associated policies, procedures and work instructions as outlined in the design control elements of the Quality Management System (QMS).
The Design Quality Engineer will be responsible to ensure that regulatory compliant technical documentation is compiled and for ensuring the ongoing compliance of the technical documentation for assigned Avalign Technologies design owned products. The Design Quality Engineer will assist in regulatory filings for Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party filing the regulatory submission.
A working knowledge of related global design regulations is required. (ISO 13485, ISO 14971, 21 CFR Part 820, and, preferably, EU Medical Device Regulation) The position requires a hands-on self-directed style, and the ability to influence and effectively communicate vertically, horizontally, across functions, externally with customers and internally with co-workers. The ideal candidate must demonstrate ability to self-direct, strong analytical abilities, and strong verbal and written communication skills. The position reports directly to the Director of Regulatory Affairs.
What You Will Do:
- Responsible for supporting a design control quality system that is complaint to ISO 13485 (latest revision), the Medical Device Directives (while active), and the EU Medical Device Regulations (MDR).
- Supports, reviews, and approves the following activities associated with new product development: identification and documentation of user needs, design inputs, outputs, verification, validation, risk assessment, and design change activities to demonstrate new product designs are supported by objective evidence in the design history file prior to product launch.
- Participate in supply chain development through Avalign division and external supplier selection and qualification with the new product development team.
- Participates in design reviews as required by the design control and development processes.
- Serve as GD&T expert for contract developer and specification developer activities.
- Assist project managers with design transfer planning and execution including advising on Avalign and vendor manufacturing process validations to support new product development.
- Support processes for Medical Device Reporting and Complaints for Avalign as specification developer products.
- Ensure required design documentation is retained in design history files and technical files to support regulatory submissions and audits.
- Support and maintain all regulatory filings for all Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party filing the regulatory submission.
- Perform corporate internal audits, either as a supporting auditor or as the lead auditor.
- Participate in external audits.
- Conduct post market surveillance for contract development and specification developer products.
- Ensure post launch product design file updates are completed following design change and post market surveillance activities.
- Write or update standard operating procedures, work instructions, or policies.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Assist in investigations of product complaints, root cause analysis, corrective action, trending and make recommendations regarding their reportability.
- Investigate and complete records related to assigned Nonconformances and CAPAs.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or other compliance issues.
What You Will Need:
- Bachelor degree or equivalent experience in an engineering or scientific field
- 5+ years of experience in quality and/or engineering role
- 2+ years of experience in medical device industry, preferred
- 2+ years of experience in quality within design control activities supporting new product development, preferred
- Experience with ISO 13485, FDA 21 CFR 820 Quality System Regulation, ISO 14971, MDR, or associated regulations.
- Ability to travel up to 25%
Preferred Qualifications
- Expertise in project management and problem solving skills, including the ability to identify, investigate and resolve technical and/or systemic issues.
- High attention to detail and persistence in resolving discrepancies
- Excellent interpersonal communication (written and verbal) skills and ability to communicate at all levels of the organization and with suppliers and customers
- Familiarity with Quality System Management software
- Familiarity with regulatory submissions including:
- Coordinating efforts associated with the preparation of regulatory documents or submissions.
- Preparation or review of regulatory submissions for domestic or international projects.
What You Won't Do:
- Feel stuck - we offer great opportunities to advance and learn
- Get bored - we make a high variety of products, so no day is the same
- Feel like a number - we're a close-knit bunch and always have each other's backs
Who You Are:
- A self-starter who thrives in a fast-paced environment
- A quick learner who is always ready to gain depth of knowledge in manufacturing processes
- A reliable individual who knows the importance of showing up when it counts
- Someone who accept assignments with an open, cooperative, positive and team-oriented approach
- Someone who is able to plan and execute plans across teams
- An effective communicator, both written and verbal
What You'll Enjoy:
- Competitive compensation and benefits package
- Comprehensive medical, dental, and vision insurance
- Paid vacation and 10 observed paid holidays per year
- Employer funded Basic Life and AD&D insurance
- Employer funded STD and LTD insurance
- Tuition reimbursement
- Great 401(k) with company match
- Generous employee referral bonus program
- Working for a thriving, performance-based company that values promoting from within and career advancement
- Temperature controlled environment
- Community involvement investing and giving back to the community
- Additional free resources such as travel assistance, EAP, etc.
Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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