Hybrid Senior Quality Engineer

at Shoulder Innovations

• Job title: Senior Quality Engineer
• Job type: Full Time
• Experience level: Senior
• Salary: $95,000 - $110,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Grand Rapids, United States

About the role

• Senior Quality Engineer supporting supplier management, CAPA, and project ownership for a medical device startup. Collaborating with teams to ensure quality and regulatory compliance in shoulder replacements.

Responsibilities

• Evaluate and approve supplier deviation and change requests for risk and compliance
• Support evaluation of suppliers including but not limited to audit support & capability assessments
• Support review of manufacturing supplier documentation, as needed
• Maintain and update the Post Market Surveillance (PMS) Report in accordance with regulatory requirements
• Analyze complaint data to identify trends and opportunities for product or process improvements
• Collaborate with internal teams to implement corrective actions based on post-market insights
• Lead CAPA investigations, including root cause analysis, action planning, and effectiveness verification
• Facilitate cross-functional CAPA teams and ensure timely closure of quality issues
• Maintain CAPA documentation in compliance with internal procedures and external regulations
• Provide guidance on complaint investigations to determine probable cause as needed
• Lead complaint investigations, coordinating with engineering, manufacturing, and quality teams as necessary; Document findings and contribute to regulatory reporting as needed
• Perform engineering tasks involving complex design constraints, material challenges, and coordination requirements
• Apply conventional engineering practices to resolve non-standard problems and support product lifecycle activities
• Work closely with Engineering, Procurement/Supply Chain, Manufacturing, and Quality Assurance teams on projects
• Provide technical input and quality oversight to ensure project success and regulatory compliance
• Take a leading role in projects for continuous improvement, business, and/or compliance needs; Including project planning, execution, and management

Requirements

• Bachelor’s degree in mechanical, biotechnology, bio-medical, industrial, or similar engineering disciplines
• 5+ years of experience in Quality Assurance, at a multidisciplinary Medical Device Company
• Familiarity with medical device regulations (ISO, EU, CFR)
• Working knowledge of FDA 21 CFR 820 regulations, ISO 13485, ISO 14971, and CGMP Good manufacturing Practices
• Knowledge of continuous improvement processes and methods
• Certified Quality Engineer (CQE) or other similar quality/reliability certifications a plus
• Extremely organized, detail oriented, and can prioritize and execute multiple tasks in a high-pressure environment
• Strong understanding of product lifecycles
• Strong ability to work independently
• Ability to write reports, business correspondence, and procedure manuals

Benefits

• Competitive wages
• Professional growth opportunities
• Great company culture