Senior Quality Engineer - Philadelphia
Leading Medical Device company is in search of a Senior Quality Engineer within the Greater Pittsburgh PA area. We are looking for candidates who want to hit the ground running and join a dynamic team. This position will be focused on new products, process validation, risk management and customer facing applications.
Candidates will need 7-10 years of experience within Medical Device Quality Engineering with a Bachelor's Degree in Engineering.
Company offers a generous salary and benefits package. If you are interested in a fast faced customer involved role please apply today!
location: CRANBERRY TOWNSHIP, Pennsylvaniajob type: Permanent
salary: $90,000 - 117,000 per year
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820
- Lead corrective and preventive actions to address non-conformances and ensure timely closure of quality events
- Support as a subject matter expert on Internal and external audits.
- Ensure compliance to internal cadence product realization procedures
- Lead and facilitate risk management activities in accordance with ISO 14971
- Lead and facilitate supplier production part approval for new products in accordance with internal procedures.
- Lead and facilitate test method validation measurement systems analysis for new products.
- Support process development and associated validation and qualification for new products.
- Monitor and ensure compliance with cleanroom environmental control procedures, including particle count, microbial monitoring, and gowning protocols.
- Monitor and ensure compliance with cleaning system control procedures, including but not limited to input controls, cytotoxicity and allowable residue levels.
- Support the validation and qualification of equipment, processes, and products, including Installation qualification, Operational qualification, and performance qualification associated with cleanroom and cleaning systems.
- Collaborate with manufacturing and engineering teams to troubleshoot and resolve production issues while maintaining cleanroom integrity and cleaning system effectiveness.
- Support continuous improvement projects to enhance manufacturing processes, reduce defects, and improve overall product quality.
- Conduct root cause analysis to investigate quality issues and develop corrective actions to prevent recurrence.
- Prepare and review technical documentation, including protocols, validation plans, work instructions, and dtandard operating procedures.
- Ensure all documentation is maintained in compliance with applicable regulations and that records are accurate and traceable.
- Track and report on key quality metrics, including defect rates and audit findings.
- Provide quality training to staff on cleanroom operations, regulatory compliance, and quality standards.
- Support cross-functional teams in addressing quality concerns and implementing best practices for continuous improvement.
qualifications:
- Experience level: Experienced
- Minimum 7 years of experience
- Education: Bachelors
- Quality
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.