Staff Quality Engineer
- Work closely with operations and business functions to ensure product and process quality performance
- Serve as the Quality representative on cross-functional teams to resolve key quality issues
- Lead quality initiatives that support compliance to standards and drive process improvements
- Develop, maintain, and improve internal procedures, SOPs, and work instructions
- Assess internal and supplier change management activities
- Apply risk management practices to manufacturing operations
- Lead internal and supplier non-conformances and ensure timely closure
- Lead CAPA projects, including investigation, implementation, and closure
- Act as SME during audits by regulatory agencies, notified bodies, and other authorities
- Lead process and quality system projects of moderate scope and complexity
- Disposition non-conforming product within the MRB
- Maintain KPIs, perform analyses, and interpret trends to drive action
- Identify and execute supplier part certification opportunities
- Support creation and maintenance of inspection methods and sampling plans
- Perform supplier control activities, including on-site and desktop audits
- Manage and maintain the Approved Supplier List (ASL)
- Lead development and improvement of manufacturing processes
- Lead supplier part approval activities for new products and changes
- Apply foundational knowledge of manufacturing processes (milling, turning, heat treatment, passivation/cleaning)
- Execute internal quality deliverables for engineering changes, product transfers, and supplier-initiated changes
- Lead complex product transfers between manufacturing sites
- Lead containment and communication activities related to potential product escapes
- Lead execution and analysis of manufacturing-related complaints and field actions
- Review, execute, and approve equipment, process, MSA, and software validation protocols/reports
- Collaborate with Regulatory on creation and revision of IFUs
- Review and approve quality records
- Utilize ERP systems for purchasing and manufacturing quality processes
- Promote Human Factors practices, including identification and mitigation strategies
- Apply statistical analysis and process control methods for CAPA, management review, and QMS processes
- Provide training (GMP, onboarding, etc.) and cross-functional support for NPD and process changes
- Provide subject matter expertise and mentorship to junior Quality team members
- Bachelor’s degree required; Engineering discipline preferred (Biomedical, Process, Mechanical)
- Minimum 5 years’ experience in a quality role within a medical device company (or equivalent regulated manufacturing experience)
- Professional quality certification (MS, CQE, CRE, Six Sigma) highly desirable
- Knowledge of quality concepts (Risk Management, CAPA, Audits, Statistics)
- Knowledge of regulatory requirements (ISO 13485, FDA QSR, EU MDR)
- Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.)
- Strong investigation and root-cause analysis skills preferred
- Process improvement and auditing skills preferred
- Ability to read engineering drawings/technical specifications preferred
- Ability to multitask, work independently, and participate in cross-functional teams
- Project management skills and ability to influence without authority
- Excellent communication, analytical, problem-solving, and technical writing skills
- High attention to detail and strong organizational skills
- Ability to meet physical requirements such as standing, walking, sitting, reaching, and standard vision capabilities
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO) and holidays
- Ongoing training and professional development
- Opportunity to grow within a fast-paced, dynamic company
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