Quality Engineer Medical Device Jobs in Oregon (NOW HIRING)

ABOUT US

The Oregon City, OR Site was established in 1969 and joined the Orchid team in 2012. The site focuses primarily on investment casting and 3D wax printing and machining and finishing and coating of orthopedic implants for extremities and large joint markets.

Robotic wax assembly, internal tool and design, finished machining, polishing, and sintered bead coating are key capabilities of the site. Our 80,000 square foot, FDA registered site employs approximately 175 team members. We ship nearly 1 million hip and knee joint implants to our customers who, in turn, provide solutions that enable patients to live longer, active lives. Fully integrated, our site manufactures medical implants from start to finish complying with the ISO 13485:2016 standard.

A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, insurance, 401(k) with company match, and paid time off. For more information, please visit www.orchid-ortho.com.

SHIFT

A BRIEF OVERVIEW
The Senior Quality Engineer supports the ongoing quality of Orchid's legacy products across all sites by focusing on a strong relationship with critical customers, working with project management and manufacturing engineers to support new product introductions and ongoing validation, and planning and executing training based on business needs.
WHAT YOU WILL DO

• Provides and documents training on standard of work instructions, policies, and procedures in a timely manner to ensure team members have the required knowledge and skills prior to performing work independently.

• Uses quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques

• Acts as a customer liaison and processes customer quality complaints, as applicable.

• Collects, Analyzes, and Presents data using statistical methodology 

• Assists suppliers with the interpretation of quality requirements, as applicable.  

• Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation 

• Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Determines machine and/or process capability through planning and/or executing Process Capability studies

• Develops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics, associated sampling plans, and required gauging.  

• Interfaces with appropriate customer contacts to clarify customer requirements

• Conceives and/or Leads productivity improvements and/or Continuous improvement projects 

• Monitors engineering production processes and products for adherence to internal and external requirements and practices. 

• Participates in pre- and post-production launch reviews providing quality engineering support

• Performs quality reviews and internal audits; evaluates data and writes associated reports

• Recommends modifications to existing quality or production standards, where applicable,  to achieve optimum quality within limits of equipment capability.

• Reviews and approves product/process and document change requests. 

• Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques.  

• Supports measuring and analyzing key metrics to monitor performance. 

• Works with cross-functional teams to solve production and quality problems. 

• Creates and manages the overall course structure and sets up course programs based on specifications. Reinforces safety expectations.  Ensures safety operating practices are demonstrated.  Reports issues/concerns to Supervisor.

• Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

EDUCATION QUALIFICATIONS

• Bachelor of Science (B.S) (Required)

• Master of Science (M.S) (Preferred)

EXPERIENCE QUALIFICATIONS

• 5+ Years of Experience (Required)

• 5+ Years of Experience in a Manufacturing Environment (Preferred)

• Experience in Medical Device Manufacturing (Preferred)

LICENSES AND CERTIFICATIONS

• Any Quality Certification (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Operational Functions - Extensive Experience

• Quality Management - Extensive Experience

• Process Management - Working Experience

• Communication - Working Experience

• Accuracy and Attention to Detail - Working Experience

• Manufacturing Safety - Extensive Experience

• Lean Manufacturing - Working Experience

• Statistical Analysis and Measurement - Working Experience

• Production Part Approval Process (PPAP) - Working Experience

• Production Runs - Extensive Experience

• Final Inspection - Working Experience

• Computer Knowledge - Working Experience

• Customer Communication - Working Experience

• QSR and ISO - Extensive Experience

• Coaching - Working Experience

• Information Processing - Working Experience

• Lean Assessment - Extensive Experience

• Problem Solving - Working Experience

WHAT WE OFFER

• Opportunity to work in a growing company

• Ability to help people live a longer, more active life

• Comprehensive benefit package

• Ability to work in an organization that values:

• • Integrity First: We do the right thing

  • Teamwork: We are one Orchid

  • Results: Our results matter

ADDITIONAL REQUIREMENTS

• Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements

• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time

• Candidates must be able to provide proof of eligibility to work in the United States through eVerify

At Orchid, we fully support a diverse and inclusive workplace and we are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, hair type, age, status as a protected veteran, or disability.

Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.