Quality Engineer Manager Jobs in Rochester, IN (NOW HIRING)

This role provides lead quality engineering support to New Product Development teams to ensure new and improved medical device products and processes comply with all applicable standards and regulations. The Quality Engineer works within a structured quality assurance system, supports design control and Design History File (DHF) creation, and partners closely with suppliers to achieve timely regulatory clearance and production readiness for orthopedic medical devices.

• Lead and support all elements of the design control system for new product development from a design quality perspective, including complete and compliant Design History File (DHF) creation.
• Execute quality engineering activities within an established quality assurance system to ensure alignment with the organization’s Quality Management System while optimizing time to regulatory approval and clearance.
• Coordinate with suppliers to review and drive regulatory clearance and production readiness, including engineering drawing review, gage development, capability studies, gage repeatability and reproducibility (gage R&R), special process validations, tolerance stack-ups, coordinate measuring machine (CMM) correlation studies, process failure mode and effects analysis (PFMEA), process flows, control plans, inspection plans, and Device History Record (DHR) reviews.
• Develop, implement, and track corrective and preventive action plans (CAPA), including internal CAPAs and supplier corrective action requests (SCARs), to address nonconformances and systemic issues.
• Provide verification and validation support, including sampling and statistical analysis, for all functions required for product clearance and approval through supplier relationships, such as mechanical testing, manufacturing special processes, packaging, and sterilization.
• Design and implement inspection methods, equipment, acceptance criteria, and sampling plans to support and maintain qualified vendors.
• Ensure ongoing compliance with design control systems and quality system regulations for medical devices.
• Plan and lead quality-related projects by identifying tasks, organizing activities into time-dependent sequences, and establishing realistic timelines to meet project objectives.
• Collaborate with cross-functional teams of engineers, clinicians, regulatory experts, quality professionals, and manufacturing specialists to solve complex problems and support the full product lifecycle from concept through manufacturing transfer.
• Support nonconformance investigations and apply structured root cause analysis methodologies to drive effective, sustainable solutions.
• Communicate clearly and professionally with internal stakeholders, suppliers, and external partners to ensure alignment on quality requirements and expectations.

• Bachelor’s degree in engineering or a related bachelor’s degree program.
• At least 3 years of experience in an orthopedic Quality Engineering position.
• Demonstrated experience with design control requirements per applicable medical device regulations such as 21 CFR Part 820 and related quality system regulations.
• Hands-on experience working within a formal Quality Management System for medical devices.
• Proficiency in developing and managing CAPA activities, including internal CAPAs and supplier SCARs.
• Experience with nonconformance management and disposition processes.
• Knowledge of statistics, process control, and process capability, including the ability to interpret and act on statistical data.
• Ability to apply statistics and statistical software (for example, Minitab) in data analysis and decision-making.
• Working knowledge of risk management for medical devices and application of failure modes and effects analysis (FMEA), including PFMEA.
• Experience using Computer-Aided Design (CAD) software such as Siemens NX or SolidWorks.
• Proficiency in geometric dimensioning and tolerancing (GD&T) and its application to engineering drawings.
• Background in inspection methods and an understanding of inspection limitations based on engineering drawings and associated tolerances.
• Experience with quality engineering activities specific to medical devices, preferably orthopedic products.
• Ability to work effectively within a team environment and build strong internal and external relationships, including with suppliers and regulatory stakeholders.
• Excellent verbal and written communication skills, including the ability to document quality activities clearly and accurately.

• Experience supporting new product development in a regulated medical device environment from concept through verification, validation, and manufacturing transfer.
• Familiarity with medical device quality standards and quality system frameworks such as ISO 9001 and other relevant ISO standards for medical devices.
• Experience executing design control activities and contributing to Design History Files (DHF) in compliance with regulatory expectations.
• Practical experience with structured problem-solving and root cause analysis methodologies, such as DMAIC, Shainin methods, and Ishikawa (fishbone) diagrams.
• Experience coordinating supplier readiness activities, including capability studies, gage R&R, special process validations, and CMM correlation studies.
• Knowledge of process control tools, control plans, process flows, and inspection planning for production processes.
• Experience designing inspection methods, acceptance criteria, and sampling plans to support vendor qualification and ongoing supplier quality.
• Demonstrated ability to plan and lead projects, organize tasks, and manage timelines in a fast-paced, innovation-focused environment.
• Comfort working in multidisciplinary teams that include engineers, clinicians, regulatory experts, quality professionals, and manufacturing specialists.
• A combination of education and experience that together demonstrates strong competency in medical device quality engineering may be considered in lieu of strict qualification matches.

This position is primarily onsite Monday through Friday on a first-shift schedule, providing close collaboration with engineering, quality, regulatory, and manufacturing teams in a medical technology development environment. Team members may choose to work either remotely or in the office on Fridays, offering some flexibility in work location at the end of the week. The role involves approximately 20% travel, which may include visits to suppliers, manufacturing partners, and other facilities to support inspections, validations, audits, and production readiness activities. The work environment emphasizes cross-functional collaboration, technical excellence, and a fast-paced approach to bringing breakthrough medical technologies from concept through design, verification, validation, regulatory strategy, and manufacturing transfer.

This is a Permanent position based out of Warsaw, IN.

The pay range for this position is $85000.00 - $90000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Comprehensive benefits package including competitive medical, dental, and vision coverage, a 401(k) retirement savings plan, and an annual performance-based incentive opportunity.

This is a fully onsite position in Warsaw,IN.

This position is anticipated to close on Sep 8, 2026.

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