Quality Engineer

Job Summary

The Quality Engineer is responsible for ensuring product quality and process control throughout the development of new and sustaining processes. This role ensures that manufacturing processes are capable, controlled, and compliant with applicable regulatory requirements (e.g., ISO 13485, FDA QSR), while supporting successful product launches and sustained production performance.

The Quality Engineer partners cross-functionally with Operations, Engineering, Metrology, and Program Management for continuous improvement as well as develop robust process control strategies that ensure consistent product quality and audit readiness. This role also works closely with customers and suppliers to ensure compliant processes and requirements are established and upheld. The Quality Engineer must have a problem-solving mindset that drives toward compliant and effective process and process improvement.

Key Responsibilities

• Assist in development, implementation, and maintenance of in-process inspection plans, control plans, and sampling strategies for manufacturing operations.
• Define and monitor critical-to-quality (CTQ) characteristics, ensuring appropriate inspection methods and acceptance criteria are applied.
• Partner with operations and engineering to identify process variation and implement real-time process control improvements.
• Author validation plans and summary reports while also supporting qualification and protocol development throughout the validation lifecycle.
• Support and drive test method validation activities for measurement and attribute testing systems.
• Collaborate with customers and internal stakeholders to ensure alignment of product specifications, drawings, and process requirements.
• Support and drive complaint and nonconformance activities.
• Support and drive CAPA activities to address systemic issues and prevent recurrence.
• Participate in internal, customer, and regulatory audits, including preparation of manufacturing records and follow‑up actions.
• Author and develop key quality processes to ensure compliant, robust, and effective execution.
• Lead or support PFMEA development and maintenance for NPI and existing processes.
• Identify process risks and implement preventive controls and mitigation strategies.
• Facilitate or lead investigation of nonconformances, deviations, and CAPA, utilizing root cause analysis tools (5 Whys, Fishbone, etc.).
• Lead or support supplier qualification and supplier management.

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical or Biomedical preferred)
• Minimum 3+ years’ experience as quality, manufacturing, or validation engineer
• Experience in medical device, aerospace, or food & beverage manufacturing
• Working knowledge of GMP environment
• Working knowledge of ISO 13485 and 21 CFR 820 or similar QMS standards and regulation (i.e. NADCAP)
• Strong working knowledge of both Quality Control and Quality Assurance principles
• Working knowledge of validation, risk management, and process control
• Working knowledge of CAPA, complaint, and nonconformance/deviation processes
• Strong statistical and data analysis skills (process capability, statistical process control, etc.)

Candidates must have valid work authorization in the U.S. that does not require employer sponsorship now or in the future.

Key Competencies

• Problem solving mindset
• Critical thinking
• Attention to detail
• Ability to work cross‑functionally and independently
• Strong organizational and time management skills
• Values integrity

Why Work With Us?

• Brand new facility located in the Fishers Life Sciences and Innovation Park
• Cafeteria onsite serving breakfast, lunch, and snacks - employees get a daily meal stipend
• 100% employer paid Dental and Vision benefits
• Modern space with brand new technology, climate-controlled production floor
• Opportunity for growth, development, and advancement
• 3 weeks of PTO, 10 paid holidays, 8 sick days