Quality Engineer

Job Title:

Quality Engineer Job Description

The Quality Engineer gathers and analyzes factual data to solve quality-related problems and ensure that products consistently meet established requirements and standards. This role identifies and implements solutions using technical experience and established precedents, plans and leads projects with realistic timelines, and fosters a collaborative team atmosphere across departments. The Quality Engineer conducts audits, inspections, and tests, and works closely with internal functions, suppliers, and external experts to achieve and maintain high quality and regulatory compliance.

• Gather relevant, factual information and data to identify, analyze, and solve quality-related problems.
• Resolve quality issues by identifying and applying solutions derived from technical experience and guided precedents.
• Plan and lead quality-related projects by defining activities, sequencing tasks, and establishing realistic timelines.
• Evaluate process methods and equipment to ensure they meet performance and quality requirements.
• Establish quality plans for equipment and processes to support general and specific product performance needs.
• Monitor the performance of processes against established standards and take action when deviations occur.
• Assure that products conform to established requirements and standards through appropriate audit, inspection, and test activities.
• Apply ISO and Quality System Regulation (QSR) requirements to internal processes and procedures, as well as those of external suppliers.
• Collaborate with suppliers on new product introductions to ensure quality and performance requirements are fully met.
• Assist Manufacturing, Sourcing, and Development teams in interpreting and applying relevant regulations and quality requirements.
• Interact with multiple functional departments, suppliers, and external experts to implement quality goals and continuous improvement initiatives.
• Develop and maintain department and project budgets to support quality engineering activities and objectives.
• Promote a team-oriented environment and work productively with all departments to achieve shared quality goals.

• Proven experience in quality engineering, with 57 years in a Quality Engineering role or an equivalent combination of education and experience.
• Strong background in quality engineering within the medical device industry, strongly preferred.
• Bachelor of Science in engineering or an alternative bachelors degree with certification as a quality engineer (e.g., CQE).
• Demonstrated ability to evaluate process methods and equipment for compliance with performance and quality requirements.
• Experience establishing and maintaining quality plans for equipment and processes.
• Hands‑on experience monitoring process performance and implementing corrective actions to maintain established standards.
• Proficiency in applying ISO standards and Quality System Regulation (QSR) requirements to processes and procedures.
• Ability to interpret and apply regulatory requirements in partnership with Manufacturing, Sourcing, and Development teams.
• Experience conducting audits, inspections, and tests to verify product and process conformance.
• Strong project planning and leadership skills, including organizing activities into time‑dependent sequences with realistic timelines.
• Ability to develop and manage department and project budgets.
• Effective collaboration and communication skills for working with cross‑functional teams, suppliers, and external experts.
• Familiarity with Failure Modes and Effects Analysis (FMEA) and related quality tools.

• Certification as a Quality Engineer (CQE) granted through the American Society for Quality (ASQ) or…