What are the responsibilities and job description for the Quality Assurance Engineer position at Orchid Orthopedics?
ABOUT US
Orchid Orthopedic Solutions is a world-leading Medical Device Contract Design and Manufacturing company, specializing in a comprehensive range of services for implants and instruments. We have substantial experience in joint reconstruction, spine, trauma, dental, and sports medicine markets. Our site, established in 2005, excels in Swiss style turning and is FDA registered and ISO 13485 certified. Join us for a rewarding career with training and growth opportunities, great benefits including quarterly bonuses, insurance, 401(k) with company match, paid time off, and engaging employee events.
SHIFT
No Shift
A BRIEF OVERVIEW
The Quality Engineer plays a key role in maintaining and enhancing the quality of Orchid's products and processes, collaborating across departments to support continual business success.
WHAT YOU WILL DO
- Provide and document training on work instructions, policies, and procedures to ensure team members possess necessary skills and knowledge.
- Utilize quality tools to propose and implement improvements such as process flowcharting, Pareto analysis, and statistical process control.
- Act as a liaison for customer quality complaints, ensuring effective resolution.
- Collect, analyze, and present data using statistical methodologies.
- Support suppliers in interpreting quality requirements.
- Contribute to quality management system (QMS) deliverables and advanced planning processes.
- Plan and conduct process and equipment validations, ensuring all critical steps are covered.
- Assist in assessing machine / process capability through capable studies.
- Develop inspection criteria that align customer requirements with manufacturing processes.
- Interface with customers to clarify and meet their quality requirements.
- Initiate and lead continuous improvement projects to enhance overall productivity.
- Monitor production processes to ensure compliance with internal and external quality standards.
- Participate in production launch reviews to provide quality engineering support.
- Conduct quality reviews and internal audits, preparing reports on findings.
- Recommend modifications to existing quality standards to optimize output.
- Review and approve product and process change requests.
- Evaluate drawings for quality requirements, ensuring appropriate application of standards.
- Track key metrics to monitor and enhance performance.
- Collaborate with cross-functional teams to solve production and quality challenges.
- Promote safety by enforcing safe operating practices and reporting issues.
- Support quality and compliance by adhering to all QMS procedures and instructions.
EDUCATION QUALIFICATIONS
EXPERIENCE QUALIFICATIONS
LICENSES AND CERTIFICATIONS
KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
PAY RATE
The pay range for this position in California is between $69,200.00 and $96,200.00, dependent on job responsibilities.
WHAT WE OFFER
ADDITIONAL REQUIREMENTS
At Orchid, we are committed to a diverse and inclusive workplace. We are an equal opportunity employer; all qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, or disability.
Salary : $69,200 - $96,200
