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43 Avalign Jobs Hiring Near You

Sr. Quality Engineer

Greenwood, IN

$84K - $113.90K/yr

Support internal and external audits to maintain regulatory, customer and Avalign compliance. * Establish effective corrective action plans. Lead in implementation of quality assurance plans, process ...

Customer Service Rep

Fort Wayne, IN

$15.75 - $21.50/hr

Collaboration across Avalign sites, commercial team and other location specific departments, to ensure customer expectations * and satisfaction is achieved, to continually improve the customer ...

Intern, German Specialty Instruments

Schaumburg, IL · On-site

$14.75 - $19.75/hr

Avalign maintains a unique, multi-national supply chain for German Specialty Instruments. Designed and manufactured in our state-of-the-art German facility, our specialty surgical instruments are ...

Production Assembler - 1st Shift

Greenwood, IN · On-site

$15.25 - $18.25/hr

If you are interested, please apply in person or via email to hr.greenwood@avalign.com. What You'll Do : * Assembles assigned product parts on assembly line in accordance with established procedures ...

Quality Engineer

Schaumburg, IL

$70.70K - $91.30K/yr

Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485. * Supports operations and ...

Accounts Payable/ Receivable Specialist

Greenwood, IN · On-site

$19.25 - $25.50/hr

Avalign is looking for an Accounts Payable/ Accounts Receivable Specialist located at our facility in Greenwood, IN. What You'll Do: Accounts Payable * Daily printing and electronic filing of ...

CNC Mill Machinist - 3rd Shift

Warsaw, IN · On-site

$21.25 - $28.25/hr

Avalign is seeking an experienced Mill Machinist on 3rd shift at our Warsaw, IN location. What You'll Do: Perform all set-up and operational functions of a 3/4/5 axis CNC milling center to produce ...

CNC Lathe Machinist - 1st Shift

Akron, OH · On-site

$21 - $26.75/hr

We are looking for a CNC Lathe Machinist to join our Avalign Integrated Medical team located in Mentor, OH on a 1st shift schedule . The CNC Lathe Machinist operates conventional, special purposes ...

Production Assembler - 2nd Shift

Greenwood, IN

$15.25 - $18.25/hr

If you are interested, please apply in person or via email to hr.greenwood@avalign.com. What You'll Do : * Assembles assigned product parts on assembly line in accordance with established procedures ...

Accounts Payable/ Receivable Analyst

Schaumburg, IL · On-site

$23.50 - $30/hr

Avalign is looking for an Accounts Payable/ Accounts Receivable Analyst located at our facility in Schaumburg, IL. What You'll Do: Accounts Payable * Daily printing and electronic filing of invoices

Responsible for day-to- day compliance and adherence to Avalign and FDA QSR requirements. * Perform spot quality checks, 5S audits, Layered Process Audits. * Help drive/ lead continuous improvement ...

... Avalign. * Act as CAPA Owner for Metrology related CAPA * Participate in Inspection plan and Gage Design discussions for New Product Introduction projects. What You'll Need: * Ability to read and ...

Production Assembly Stager - 1st Shift

Greenwood, IN · On-site

$15.25 - $18.25/hr

We are looking for an Assembly Stager to join our Greenwood, IN facility on a 1st shift schedule. You will prepare and stage parts for assembly, including reading work orders and sorting parts. What ...

Sr. Manufacturing Engineer

Warsaw, IN · On-site

$87.70K - $120K/yr

Our facility located in Warsaw, IN is looking for a Sr. Manufacturing Engineer. The primary purpose for the Sr. Manufacturing Engineer is to contribute technical manufacturing, project management ...

Laser Etch Operator - 3rd Shift

Greenwood, IN

$16.75 - $21.25/hr

We are looking for a Laser Etch/ Engrave Operator to join our Greenwood, IN location on a 3rd shift schedule . You will set up and operate Laser Engraving machine to engrave/etch metal parts. What ...

CNC Lathe Operator - 2nd Shift

Mentor, OH · On-site

$19.75 - $25/hr

We are looking for a CNC Lathe Machine Operator for a 2nd shift schedule. We are willing to provide training! What You'll Do: * Independently set up, operate, and troubleshoot Star CNC Swiss machines ...

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Sr. Quality Engineer

avalign

Greenwood, IN

$84K - $113.90K/yr

Other

Posted 29 days ago


Job description

The Sr. Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure quality standards of all products are met.

What You’ll Do:

 

  • Acts as main Quality Engineering contact for assigned customers and projects.
  • May supervise quality technicians and/or inspectors as needed at the manufacturing facility.
  • Provides quality leadership in manufacturing inspection plan development.
  • Provides leadership to engineering and manufacturing functions for validation planning and NPI transfer activities. Assists teams in determining validation needs and requirements.
  • Provides ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes.
  • Primary quality representative for site supplier management and resolution of supplier nonconformances
  • Support internal and external audits to maintain regulatory, customer and Avalign compliance.
  • Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Recommends test methods and statistical process control procedures for achieving required levels of product reliability.
  • Conducts or guides testing and data analysis which demonstrate that new processes meet acceptance criteria, including capability studies and Gage R&R studies.
  • Serves as a quality representative to assigned manufacturing areas and/or customers. Responsible for ensuring compliance with Avalign procedures; customer requirements;  and industry regulations, including FDA Quality System Regulation and ISO 13485.
  • Supports operations and engineering teams to ensure the Material Review Board process is followed.
  • Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements;  and complaint/NC/CAPA investigations.
  • Submit documentation to customers for new product launches and legacy product documentation requests.
  • Manages Non-Conforming Material Reports system and dispositions all non-conforming product.
  • Enhances and drives product risk management activities.  Ensures identified activities and mitigations are executed. 
  • Participates in technical discussions and risk-based decision making.
  • Identifies opportunities and recommends improvements to quality system and manufacturing processes; drives continuous improvement. 

What You’ll Need:

  • Candidates should have a BS in an engineering science plus at least 5 years of manufacturing experience, or an equivalent combination of education and experience.
  • Ability to utilize statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
  • Ability to read and interpret blueprints as well as have a Knowledge of GD&T, and Inspection methods.
  • An understanding of quality standards (ISO 13485) & regulatory requirements (21CFR820).
  • New production introduction/process development experience in a manufacturing environment highly preferred.