Quality Engineer

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.

• 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

• Education: Bachelor's (BS) or advanced degree in an engineering or technical discipline.
• Industry
  
  Experience:
  
  Experience with in the medical device industry.
• 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.