Top 40 Senior quality engineer Jobs in Elkhart, In

Senior Quality Engineer
Complexus Medical —Mishawaka, IN
- $85,000 - $110,000 a year
- Full-time
- Engineering
- Travel
- In-person
- Health savings account
- Health insurance
Quick Apply
Engineer, Quality II - Senior
Dynamic Metals LLC —Elkhart, IN
- Full-time
- 3 years
- High school diploma or GED
- Bachelor's degree
Quick Apply
Senior Supplier Quality Engineer
Honeywell Aerospace —South Bend, IN
- Full-time
- Electrical experience
- Senior level
Sr. Quality Engineer
Optimal Inc. —Elkhart, IN
- $80,000 - $85,000 a year
- Full-time
- Senior level
- Electrical Engineering
- Communication skills
Quick Apply
Design Engineer
Spheros Germany GmbH —Elkhart, IN
- Full-time
- Organizational skills
- Senior level
- Associate's degree
- Life insurance
Advanced Manufacturing Engineer II
Honeywell Aerospace —South Bend, IN
- Full-time
- Mid-level
Advanced Mfg Engineer Sr
Honeywell Aerospace —South Bend, IN
- Full-time
- Manufacturing
- Senior level
Junior Design Engineer
Crew Seating —Elkhart, IN
- $55,000 - $65,000 a year
- Full-time
- Engineering
- Ability to lift 50 pounds
- Continuous improvement
- Health insurance
- Dental insurance
Quick Apply
Project Engineer
Terracon —Niles, MI
- 5 years
- Engineering
- Driver's License
- Paid holidays
- Health insurance
Staff Engineer
Terracon —Niles, MI
- Engineering
- Laboratory experience
- Driver's License
- Paid holidays
- Health insurance
Staff Engineer
WEAVER CONSULTANTS GROUP LLC —Granger, IN
- Weekends as needed
- Construction site
- Bachelor of Science
- Driver's License
Quick Apply
Supplier Development Engineer - Casting and Forging, South Bend IN, or Honeywell approved site, or Remote
Honeywell Aerospace —South Bend, IN
- Full-time
- Up to 50% travel
- Travel
- Senior level
10d
Senior Resident Controls Engineer
E Tech Group —South Bend, IN
- 5 years
- Bachelor of Science
- Engineering
- Paid holidays
- Health insurance
Quick Apply
Senior Civil Engineer
Abonmarche Consultants, INC —South Bend, IN
- Full-time
- 5 years
- Residential
- Senior level
Senior Engineer
City of South Bend —South Bend, IN
- $83,000 - $88,500 a year
- Full-time
- Background check
- Clean driving record
- Pass drug screening
Quick Apply
Engineer III Electrical
Renegade —Bristol, IN
- Full-time
- Microsoft Outlook
- Office
- Mentoring
Senior Water/Wastewater Process Engineer/Project Manager
Donohue & Associates —South Bend, IN
- Bachelor of Science
- Engineering
- Budgeting
- Profit sharing
- Paid holidays
Senior Water Treatment Engineer
Lochmueller Group —South Bend, IN
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Driver's License
- Loan repayment program
- Disability insurance
Quick Apply
Mission Critical - Sr. Electrical Specialist
Engineering Economics, Inc. —South Bend, IN
- $10 - $11 an hour
- Full-time
- Hybrid work
- 6 years
- Construction site
- Military
- Profit sharing
- Health savings account
9d
Mission Critical - Electrical Specialist
Engineering Economics, Inc. —South Bend, IN
- $10 - $11 an hour
- Full-time
- Hybrid work
- PMP
- Construction site
- Engineering
- Profit sharing
- Health savings account
9d

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Senior Quality Engineer

Complexus Medical -
Mishawaka, IN

Quick Apply

Job Details

Full-time
$85,000 - $110,000 a year

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

Quick Apply

Refine Your Search

senior quality engineer jobs in elkhart, in

Senior Quality Engineer

Engineer, Quality II - Senior

Senior Supplier Quality Engineer

Sr. Quality Engineer

Design Engineer

Advanced Manufacturing Engineer II

Advanced Mfg Engineer Sr

Junior Design Engineer

Project Engineer

Staff Engineer

Staff Engineer

Supplier Development Engineer - Casting and Forging, South Bend IN, or Honeywell approved site, or Remote

Senior Resident Controls Engineer

Senior Civil Engineer

Senior Engineer

Engineer III Electrical

Senior Water/Wastewater Process Engineer/Project Manager

Senior Water Treatment Engineer

Mission Critical - Sr. Electrical Specialist

Mission Critical - Electrical Specialist

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