Job Description

JOB REQUIREMENTS: The ideal candidate is a hands-on, strategic quality

leader with a strong background in medical device manufacturing and 3D printing technologies, capable of fostering a culture of quality and continuous improvement within a growing organization. This is a full-time, on-site role with no travel required. Key Responsibilities Quality Management System (QMS) Development & Oversight Establish, implement, and maintain a comprehensive Quality Management System in alignment with ISO 13485, FDA 21 CFR Part 820, MDSAP, and MDR requirements. Ensure compliance with all applicable medical device regulatory standards and customer requirements. Develop and document quality processes, policies, and standard operating procedures (SOPs) to support production startup and scale-up. Lead the site\'s efforts to obtain and maintain relevant quality certifications and regulatory approvals. Product Quality & Compliance Oversee all product quality control and quality assurance activities from incoming inspection through final release of finished products. Review and approve product releases to ensure full compliance with specifications and regulatory requirements. Partner with production, R&D, and engineering teams to implement robust in-process controls and drive defect prevention strategies. Lead root cause investigations, CAPA development, and risk management activities to ensure effective and sustainable corrective actions. Leadership & Team Management Build, mentor, and lead a growing team of 67 quality professionals. Provide training and guidance to ensure adherence to QMS requirements and promote a strong culture of quality and accountability. Collaborate closely with cross-functional leaders (Operations, Engineering, Supply Chain, and Regulatory Affairs) to drive quality alignment across the organization. Customer Feedback & Continuous Improvement Establish and maintain a customer feedback and complaint-handling system in accordance with regulatory requirements. Collect, analyze, and report post-market surveillance data to identify trends and guide continuous improvement initiatives. Conduct regular quality review meetings to assess product performance, customer complaints, and audit findingsdeveloping actionable improvement plans. Audits & Management Reviews Lead internal quality audits and prepare for external audits from regulatory agencies and notified bodies. Drive management reviews by providing data-driven insights, key performance indicators (KPIs), and recommendations for system enhancements. \*\** OTHER EXPERIENCE AND QUALIFICATIONS: Qualifications Bachelor\'s degree or higher. 5+ years of progressive quality management experience in the medical device industry, preferably with Class II or III devices. Deep understanding of ISO 13485, FDA 21 CFR 820 (QSR), MDSAP, and MDR quality system requirements. Experience with 3D printing/additive manufacturing processes and familiarity with their quality control challenges. Proven success in establishing or scaling quality systems in a new or expanding facility is highly preferred. Strong leadership, team-building, and organizational skills with the ability to thrive in a fast-paced start-up environment. Excellent communication, analytical, and problem-solving skills with a continuous improvement mindset. \*\** APPLICATION INSTRUCTIONS: E-Mail a Rsum: lminik@sitestaffinginc.com Other: SITE Staffing does not accept phone calls regarding any job postings. If interested in a position, please submit your resume for review. If accepted as a possible candidate you will be contacted within 48 hrs. We do not contact those candidates that are not invited to complete our application. If you have any questions regarding our postings, we ask that you submit those inquiries via email. This position is listed by a private employment agency. The agency is the legal employer. No fee will be charged of the job applicant.

Job Tags

Full time,

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