Job Details

ABOUT US

At Orchid, we are committed to creating high-quality hip and knee joint implants that enhance our customers' active lives. Our 80,000 square foot facility employs around 300 dedicated team members who take pride in manufacturing medical implants from start to finish. Joining Orchid means embracing numerous growth opportunities and enjoying an attractive benefits package, including performance bonuses, comprehensive insurance, a 401(k) with company match, and paid time off.

For more details, check our website.

SHIFT

No Shift ($0) (United States of America)

A BRIEF OVERVIEW
The Senior Quality Assurance Engineer plays a vital role in maintaining the quality of our products by building strong relationships with key customers and collaborating closely with project management and manufacturing engineers. This role also involves facilitating new product introductions and ongoing validation, along with developing training programs aligned with business needs.

WHAT YOU WILL DO

• Provide and document training on standard work instructions, policies, and procedures to ensure team members possess the necessary skills before working independently.
• Utilize quality improvement tools such as process flowcharting, Pareto analysis, regression analysis, significance tests, design of experiments, and statistical process control.
• Serve as a liaison for customer quality complaints, managing and responding as needed.
• Collect, analyze, and present data through advanced statistical methods.
• Assist suppliers in understanding quality requirements effectively.
• Contribute to the development of essential Quality Management System (QMS) deliverables, including complaint analysis and risk assessments.
• Plan and conduct process and equipment validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Determine machine and process capability through comprehensive Process Capability studies.
• Develop inspection criteria connecting customer requirements with manufacturing processes.
• Engage with customers to clarify their requirements thoroughly.
• Lead and innovate productivity improvements and continuous improvement initiatives.
• Monitor production processes and products to ensure compliance with internal and external standards.
• Participate in production launch reviews, providing vital quality engineering support.
• Perform quality reviews, internal audits, and data evaluations, documenting findings in reports.
• Recommend modifications to enhance quality standards and optimize production processes.
• Review and authorize product/process change requests and documentation.
• Evaluate drawings against quality requirements, ensuring proper application of specifications and inspection techniques.
• Track and measure key metrics to monitor performance continuously.
• Collaborate with cross-functional teams to address production and quality challenges.
• Define and manage training programs, reinforcing safety expectations and practices.
• Ensure compliance with all quality procedures, work instructions, and QMS documentation.

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
• Effective Communication - Working Experience
• Attention to Detail - Working Experience
• Manufacturing Safety - Extensive Experience
• Lean Manufacturing Techniques - Working Experience
• Statistical Analysis and Measurement - Working Experience
• Production Part Approval Process (PPAP) - Working Experience
• Final Inspection Procedures - Working Experience
• Computer Proficiency - Working Experience
• Customer Communication - Working Experience
• QSR and ISO Standards - Extensive Experience
• Coaching Skills - Working Experience
• Problem-Solving Abilities - Working Experience

WHAT WE OFFER

• Opportunity to grow within a vibrant company
• A chance to positively impact lives through our products
• Comprehensive benefits package
• An organization that values integrity, teamwork, and results

ADDITIONAL REQUIREMENTS

• Selected candidates may need to complete a pre-employment background check and drug screening.
• Applicants must be authorized to work for any employer in the U.S.
• Candidates must provide proof of eligibility to work in the United States through eVerify.

Orchid fosters a diverse and inclusive workplace and is an equal opportunity employer. All qualified applicants will receive consideration for employment irrespective of race, color, religion, sex, sexual orientation, gender identity, national origin, age, or disability.