What are the responsibilities and job description for the Quality Assurance 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. Join us at Orchid for excellent career growth opportunities, a competitive benefits package that includes performance bonuses, insurance, a 401(k) with company match, and generous paid time off.
No Shift ($0) (United States of America)
POSITION OVERVIEW
The Quality Assurance Engineer will play a pivotal role in ensuring the ongoing quality of Orchid's products. You will work closely with project management and manufacturing engineers to facilitate new product introductions and ongoing validation processes.
RESPONSIBILITIES
- Contribute to essential Quality Management System (QMS) deliverables, including complaint and risk analysis, failure mode and effects analysis, CAPA, and process / equipment / software verification / validation.
- Plan and execute process and equipment validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Collaborate with customer contacts to clarify and meet requirements.
- Evaluate machine and process capabilities through Process Capability studies.
- Develop inspection criteria that align customer requirements with manufacturing processes, including key characteristics, sampling plans, and gauging requirements.
- Lead productivity and continuous improvement projects.
- Monitor production processes for compliance with internal and external standards.
- Participate in pre-production and post-production launch reviews to provide quality support.
- Conduct quality reviews and internal audits, analyze data, and prepare reports.
- Propose modifications to existing quality and production standards to enhance product quality within equipment capabilities.
- Act as a liaison for customer quality complaints.
- Collect, analyze, and present data utilizing statistical methodologies.
- Assist suppliers in interpreting quality requirements.
- Review and approve product / process change requests.
- Utilize quality tools to implement process improvements, including statistical process control, gauge repeatability, and regression analysis.
- Review and analyze drawings for quality requirements, ensuring proper application of specifications.
- Support the measurement and analysis of key performance metrics.
- Collaborate with cross-functional teams to resolve production and quality issues.
- Promote safety standards and report safety concerns to management.
- Adhere to all quality and compliance procedures and protocols.
- Complete all mandatory training requirements.
EDUCATION
EXPERIENCE
CERTIFICATIONS
KEY SKILLS
PHYSICAL REQUIREMENTS
WORK ENVIRONMENT
WE OFFER
REQUIREMENTS
At Orchid, we are committed to fostering a diverse and inclusive workplace and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters and employment agencies.
