What are the responsibilities and job description for the Quality Engineer position at Orchid Orthopedics?
ABOUT US
The Oregon City, OR site was established in 1973 and joined the Orchid team in 2012. Our 80,000 square foot facility employs approximately 300 team members. We specialize in hip and knee joint implants that enable our customers to live a longer active life. We are a full-service plant, meaning our team can manufacture medical implants from start to finish in-house. 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
No Shift ($0) (United States of America)
A BRIEF OVERVIEW
The Quality Engineer II supports the ongoing quality of Orchid's legacy products and works with project management and manufacturing engineers to support new production introduction and ongoing validation.
WHAT YOU WILL DO
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).
Interfaces with appropriate customer contacts to clarify customer requirements
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.
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.
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.
Reviews and approves product / process and document change requests.
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.
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.
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).
Completes all required training.
EDUCATION QUALIFICATIONS
Bachelor of Science (B.S) (Required)
EXPERIENCE QUALIFICATIONS
3 Years of Experience (Required)
3 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 - Working Experience
Quality Management - Working Experience
Process Management - Working Experience
Communication - Basic Knowledge
Accuracy and Attention to Detail - Working Experience
Manufacturing Safety - Working 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
Problem Solving - Working Experience
PHYSICAL DEMANDS
Must be able to remain in a stationary position - Frequently
Must be able to move about the inside of the building - Occasionally
Must be able to move equipment around the building - Occasionally
Must be able to position oneself and move under / around / over equipment - Occasionally
Must be able to communicate and exchange information with others - Frequently
Must be able to distinguish and detect information such as writing and defects - Frequently
WORKING CONDITIONS
Noise - Occasionally
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
ADDITIONAL REQUIREMENTS
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.
