About the role
About the Role
Seeking a detail-oriented Quality Engineer to provide dedicated support to commercial production operations, ensuring products consistently meet safety and effectiveness standards for patients. This role is responsible for driving day-to-day quality operations, performing equipment qualifications, leading root-cause evaluations for compliance issues, and maintaining alignment with strict regulatory standards across cross-functional teams.
Key Responsibilities
- Support incoming material receiving and inspection Support materials receiving and inspection activities including preparation, inspection, and disposition of incoming materials.
- Ensure quality of produced products by understanding production process, reviewing batch record documentation, and performing/reviewing in-process and finished goods inspections
- Assist in the release of sterile products by reviewing sterilization results, labeling products, and addressing any non-conformance.
- Assist in analyzing and resolving complex Manufacturing and Compliance issues (e.g., CAPA, non-conformance, audit observations)
- Support controlled facilities environment by participating in environmental monitoring, calibration, and preventive maintenance activities
- Perform equipment qualification for any new and changing equipment requirements
- Generate and evaluate metrics that are used to identify negative trends and areas for improvement and inspecting products returned from the field
- Participate with a cross-functional team on field complaint investigations
- Perform hands on product testing to support ongoing required product changes
Qualifications & Experience
- Education: Bachelor's (BS) or advanced degree in an engineering or technical discipline. Open to new graduates!
- Regulatory Mastery: Solid understanding of Quality System requirements as outlined in FDA 21 CFR Part 820 and ISO 13485, with the ability to translate and communicate regulatory requirements to cross-functional partners.
- Interpersonal & Adaptive Skills: High emotional intelligence and strong written/verbal communication skills necessary to collaborate effectively in a fast-paced environment
- Core Competencies: Self-starter mindset with demonstrated ability to manage multiple tasks simultaneously with exceptional attention to detail, organization, and accuracy.
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