ABOUT US Orchid Orthopedic Solutions is a leading Medical Device Contract Design and Manufacturing company, offering a broad range of services for implants and instruments. We specialize in joint reconstruction, spine, trauma, dental, and sports medicine markets, with a focus on Swiss style turning. Our facilities are FDA registered and ISO 13485 certified. Joining Orchid means access to training and growth opportunities, amazing 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 II plays a crucial role in ensuring the quality of Orchid's legacy products and collaborates with project management and manufacturing engineers on new production introductions and ongoing validation efforts. This position is key in supporting our quality management system (QMS) sustainability, lean practices, and driving continuous improvement across our operations. WHAT YOU WILL DO Support quarterly management review activities. Complete all required training. Utilize quality tools for implementing improvements including process flowcharting, Pareto analysis, regression analysis, and more. Serve as a liaison to customers for quality complaints. Collect, analyze, and present data using statistical methodologies. Assist suppliers with quality requirement interpretations. Contribute to the development of essential QMS deliverables and Advanced Product Quality Planning (APQP). Plan and conduct process and equipment validations, including IQ, OQ, and PQ. Collaborate with customers to clarify requirements. Determine machine and process capabilities through capability studies. Develop inspection criteria linking customer needs to manufacturing processes. Lead continuous improvement projects. Monitor production processes for compliance with standards. Participate in pre- and post-production launch reviews, providing quality engineering support. Conduct quality reviews and internal audits, writing associated reports. Recommend modifications to optimize quality within equipment capabilities. Review and approve product/process and document change requests. Evaluate drawings for quality requirements and inspection methods. Measure and analyze key metrics to assess performance. Collaborate with cross-functional teams to resolve production and quality issues. Promote safety practices and report significant issues to management. Support quality and compliance following QMS procedures and instructions. EDUCATION QUALIFICATIONS Bachelor's Degree (Required) Bachelor of Science (B.S) (Preferred) EXPERIENCE QUALIFICATIONS 3+ Years of Experience (Required) 3+ Years 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 Attention to Detail - Working Experience Manufacturing Safety - Working Experience Lean Manufacturing - Working Experience Statistical Analysis - Working Experience Production Part Approval Process (PPAP) - Working Experience Final Inspection - Working Experience Computer Proficiency - Working Experience Problem Solving - Working Experience PHYSICAL DEMANDS Ability to remain stationary - Frequently Ability to move around the facility - Occasionally Ability to maneuver equipment - Occasionally Ability to navigate around equipment - Occasionally Ability to communicate with others - Frequently Ability to detect writing and identify defects - Frequently WORKING CONDITIONS Noise Exposure - Occasionally PAY RATE For positions in California, the pay for this job type ranges from $86,300.00 to $100,000.00, based on job responsibilities. WHAT WE OFFER Opportunity to work in a growing company. Impact lives by helping people lead longer, active lives. Comprehensive benefit packages. Work in an organization that values: Integrity First: We do what’s right. Teamwork: We are one Orchid. Results: Our results matter. ADDITIONAL REQUIREMENTS Offer of employment may require a pre-employment background check and drug screening. Candidates must provide proof of eligibility to work in the United States. At Orchid, we embrace diversity and inclusion in our workplace and are 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, status as a protected veteran, or disability.