Senior Quality Engineer

Senior Quality Engineer Complexus Medical - 3.3 Mishawaka, IN Job Details Full-time $85,000 - $110,000 a year 3 days ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications Statistics Client relationship management ISO certification process Customer communication Customer relationship building Defect resolution root cause analysis Quality control statistical data analysis Engineering Statistical Process Control Vendor compliance audits Supplier audits Production validation processes Medical device manufacturing facility experience Certified Quality Auditor Regulatory/legal compliance standards in production Biomedical regulatory compliance OEM Test validation method Supplier risk evaluation FDA regulations Statistical analysis tools Failure analysis Full Job Description

SENIOR QUALITY ENGINEER POSITION OVERVIEW

Complexus Medical is seeking an experienced Senior Quality Engineer to serve as the primary quality interface between Complexus and our OEM medical device customers. This is a highly customer-facing role — you will be the trusted quality partner that our OEM customers rely on for communication, issue resolution, audit hosting, and quality performance reporting throughout the product lifecycle. In addition to managing day-to-day customer quality relationships, you will serve as an internal subject matter expert in quality systems, regulatory compliance, and risk management within our contract manufacturing environment for precision orthopedic instruments. Department Quality Assurance Location On-site - Plymouth, IN or Mishawaka, IN (Preferred) Employment Type Full-Time Experience Required 10-15 Years Travel Up to 40% (supplier audits, customer sites, Complexus Medical facilities)

KEY RESPONSIBILITIES

Quality Management System (QMS)

• Maintain the Quality Management System in compliance with ISO 13485 and applicable FDA regulations (21 CFR Part 820).
• Assist in leading

ISO 13485

surveillance audits, FDA inspections, and customer audits; manage audit readiness, host audit teams, and drive timely closure of all findings.

• Develop, review, and approve controlled documents including SOPs, work instructions, and quality plans.
• Act as the primary quality point of contact for all OEM medical device customers — owning the quality relationship from onboarding through ongoing production, including regular communication, quality performance reviews, and issue escalation.
• Represent Complexus in customer-facing quality meetings, design reviews, and program updates; build strong long-term relationships with customer quality and regulatory teams. OEM Customer Quality Management
• Serve as the main point of contact for customer quality requirements, translating OEM specifications and quality expectations into actionable internal standards and work instructions.
• Proactively communicate quality performance metrics, non-conformance status, and CAPA progress to OEM customers on a regular cadence.
• Lead customer onboarding from a quality perspective, including review of customer quality agreements, supplier questionnaires, and quality system assessments.
• Manage and resolve customer complaints and quality escapes; ensure thorough root cause analysis and corrective actions are communicated back to the customer in a timely manner.
• Support customer-initiated audits and visits; prepare documentation packages, host audit teams on-site, and ensure all findings are addressed and closed. Regulatory Affairs & Compliance
• Ensure manufacturing processes and documentation comply with

FDA 21 CFR

Part 820, ISO 13485 and other applicable international standards.

• Maintain and own Device Master Records (DMR), ensuring all manufacturing documentation is current, controlled, and audit-ready.
• Interpret and communicate regulatory changes that may affect manufacturing processes or product compliance. Risk Management
• Lead risk management activities in accordance with ISO 14971, including hazard identification, risk analysis, and risk control verification.
• Facilitate Process FMEAs with cross-functional teams, ensuring risk acceptability criteria are properly applied.
• Integrate risk management outputs into validation activities, control plans, and manufacturing documentation.
• Maintain and update risk management files throughout the product lifecycle. Supplier Quality Management
• Lead the Approved Supplier List (ASL) program including supplier qualification, performance monitoring, and re-qualification activities.
• Conduct on-site supplier audits and assessments; issue and track corrective action requests to closure.
• Collaborate with procurement to develop supplier quality agreements and establish incoming inspection criteria.
• Partner with OEM customers to align supplier requirements and communicate supply chain quality performance. Product & Process Quality
• Support Process validation (IQ/OQ/PQ) for new and transferred instrument manufacturing programs.
• Perform root cause analysis and lead CAPA investigations for non-conformances, customer complaints, and field issues.
• Oversee inspection and test method development, including MSA/Gauge R&R studies and acceptance criteria definition.
• Provide quality engineering support during new product introduction (NPI) and engineering change orders (ECOs).

REQUIRED QUALIFICATIONS

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 10-15 years of progressive quality engineering experience in the medical device industry.
• Demonstrated expertise with

ISO 13485 QMS

requirements and

FDA 21 CFR

Part 820 Quality System Regulations.

• Hands-on experience with

ISO 14971

risk management methodology, including authoring FMEAs and risk management files.

• Strong background in supplier quality management, including conducting supplier audits and managing CARs.
• Experience working within a contract manufacturing or OEM supply chain environment.
• Proficiency with validation methodologies (IQ/OQ/PQ) and statistical tools (SPC, MSA, DOE).
• Skilled in root cause analysis techniques (8D, Fishbone, 5-Why, Fault Tree Analysis).
• Exceptional written and verbal communication skills; proven ability to manage OEM customer relationships and present technical quality information to external stakeholders.
• Comfortable serving as an external face of the quality organization —representing Complexus professionally in customer meetings, audits, and escalations.

PREFERRED QUALIFICATIONS

• Experience as a supplier quality engineer or quality liaison embedded within or supporting an OEM customer relationship.
• Background in the manufacturing of surgical instruments, preferably within orthopedic specialties such as hip, knee, spine, shoulder, or foot.
• ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification.

Pay:

$85,000.00 - $110,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person