The Quality Engineer is responsible for ensuring product quality, process capability, and manufacturing effectiveness through the application of quality engineering principles, risk-based decision making, data analysis, and continuous improvement methodologies.
This role serves as the primary quality partner to Manufacturing, Manufacturing Engineering, Sustaining Engineering, Research & Development, and Supply Chain teams to identify and mitigate quality risks, improve process performance, reduce cost of poor quality, and ensure compliance with applicable regulatory and quality system requirements.
The Quality Engineer provides technical leadership for nonconformance investigations, process validation activities, quality planning, inspection strategies, statistical analysis, and manufacturing quality improvement initiatives throughout the product lifecycle.
Essential Duties & ResponsibilitiesOperational Quality Support- Serve as the primary Quality representative for assigned manufacturing processes, product families, or value streams.
- Provide day-to-day quality engineering support to manufacturing operations.
- Participate in production issue resolution and escalation activities.
- Evaluate manufacturing quality performance and identify opportunities for improvement.
- Support achievement of quality, delivery, and operational performance objectives.
Nonconformance & Investigation Support- Lead and facilitate investigations related to manufacturing nonconformances and product quality issues.
- Apply structured root cause analysis methodologies to identify underlying causes of defects and failures.
- Develop and implement effective corrective actions within assigned areas of responsibility.
- Support Material Review Board (MRB) activities and disposition decisions.
- Identify recurring trends and systemic quality issues requiring escalation.
Quality Planning & Risk Management- Participate in product and process risk assessments throughout the product lifecycle.
- Support development and maintenance of risk management documentation.
- Evaluate proposed process, material, equipment, and design changes for potential quality and compliance impacts.
- Collaborate with cross-functional teams to ensure quality considerations are incorporated into business decisions.
Process Validation & Verification- Support process validation and verification activities and revalidation efforts.
- Assist in development of validation protocols and reports.
- Evaluate process performance data to verify ongoing process effectiveness.
- Support equipment qualification and process capability initiatives.
Inspection & Measurement Systems- Develop and maintain inspection strategies, acceptance criteria, and test methods.
- Create and improve inspection methods, sampling plans, and quality controls.
- Author and/or facilitate First Article Inspection documentation, coordination, and execution
- Evaluate effectiveness of measurement systems and inspection processes.
- Assist with gage selection, measurement studies, and continuous improvement of inspection activities.
Data Analysis & Continuous Improvement- Analyze quality, manufacturing, and customer performance data to identify trends and improvement opportunities.
- Utilize statistical tools and methodologies to support data-driven decision making.
- Lead or participate in continuous improvement projects focused on reducing defects, scrap, rework, complaints, and cost of poor quality.
- Develop and maintain quality performance metrics and reporting.
Product Development & Change Management Support- Participate in new product development and product transfer activities.
- Support design verification, validation, and manufacturing readiness activities as assigned.
- Review engineering changes for potential quality impacts.
- Collaborate with Configuration & Change Management personnel to ensure effective implementation of approved changes.
Regulatory & Quality System Compliance- Ensure assigned activities comply with applicable quality system and regulatory requirements.
- Support internal and external audits as a subject matter expert.
- Maintain accurate and complete quality records.
- Promote a culture of quality, compliance, accountability, and continuous improvement.
Knowledge, Skills & AbilitiesTechnical Knowledge- Strong understanding of quality engineering principles and methodologies.
- Working knowledge of ISO 13485 and FDA Quality System Regulation requirements.
- Knowledge of risk management principles and tools.
- Understanding of process validation methodologies.
- Understanding of statistical methods and process capability analysis.
- Familiarity with manufacturing processes and process controls.
Communication & Leadership- Ability to lead cross-functional investigations and improvement activities.
- Strong written and verbal communication skills.
- Ability to influence without direct authority.
- Ability to effectively communicate technical information to diverse audiences.
Education & ExperienceRequired- Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, Biomedical Engineering, or related technical discipline.
- Minimum 3 years of experience in quality engineering, manufacturing engineering, process engineering, or related technical role.
Preferred- Medical device industry experience.
- Experience in an ISO 13485-regulated environment.
- ASQ Certified Quality Engineer (CQE) or equivalent certification.
- Experience with validation activities and risk management.
- Experience with statistical analysis software.
- Lean Six Sigma certification.
Key Performance ExpectationsSuccess in this role is demonstrated through:
- Reduction in defects, scrap, and rework.
- Timely and effective investigation closure.
- Improved process capability and manufacturing performance.
- Successful validation and implementation of process improvements.
- Effective support of product launches and engineering changes.
- Positive audit outcomes.
- Development of sustainable quality controls and risk mitigations.
- Strong cross-functional partnership and leadership.
Medical, Dental, and Vision coverage starts on Day One! Free life insurance, short and long-term disability insurance, Telehealth Appointments, and Employee Assistance Program. Immediate vesting of 401(k) matching. Generous PTO and 11 Paid Holidays a year. And, most importantly...truly meaningful work!
