Senior Quality Engineer
Shoulder Innovations
full-time
Posted on:
Location Type: Hybrid
Location: Grand Rapids • Missouri • United States
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Salary
💰 $95,000 - $110,000 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
root cause analysisCAPA investigationscomplaint investigationsengineering practicesproject planningproject executionquality oversightdata analysisregulatory complianceaudit support
Soft Skills
organizational skillsdetail orientedability to prioritizeability to execute multiple tasksindependent workcollaborationleadershipcommunicationproblem-solvingtime management
Certifications
Certified Quality Engineer (CQE)