Quality Engineer Medical Devices
2 days ago
Sterling Engineering Inc. is seeking a highly skilled Quality Validation Engineer to join our team.
About the RoleThe Quality Validation Engineer will be responsible for ensuring the highest quality standards in medical device manufacturing. Key responsibilities include:
- Project Planning: Planning, coordinating, and executing validation projects to meet customer and internal quality objectives.
- Troubleshooting: Collaborating with cross-functional teams to investigate and resolve customer complaints.
- SUPPLIER MANAGEMENT: Evaluating and managing supplier performance, fostering strong partnerships.
- COMPLIANCE AND QUALITY SYSTEMS: Coordinating and leading validations, change control activities, and written protocols. Ensuring compliance with ISO and FDA QSR quality systems and company policies.
- CONTINUOUS IMPROVEMENT: Identifying and executing continuous improvement projects.
REQUIREMENTS:
- Bachelor's degree in Engineering, Science, or related field.
- 3+ years of experience in Quality position, preferably in Medical Device industry (ISO 13485).
- Proven expertise in technical writing, IQ/OQ/PQ, and equipment validation.
- Excellent communication skills, with fluency in English.
- Proficiency in advanced mathematical concepts and intermediate statistical knowledge.
- Six Sigma experience, training, or certification preferred. SAP experience an added advantage.
- Ability to travel up to 25% domestically and internationally.
SALARY RANGE:
$95,000-$115,000 per year, based on qualifications and location. Benefits include health insurance, retirement plan, and opportunities for professional growth and development.
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