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Quality Operations Manager

Job Purpose:

Oversight of Quality Operations activities (Quality Assurance & Quality Control) across the Company’s manufacturing location ensuring compliance to and continuous improvement of the Quality Management System. This leader will be expected to apply his/her knowledge of Quality Assurance and Quality Control principles and techniques to positively collaborate and lead in in the advancement and effective operation of the QMS. In parallel, the candidate shall also ensure QA/QC personnel are adequately trained and developed to advance the business objectives of the Company.

Job Purpose:

Oversight of Quality Operations activities (Quality Assurance & Quality Control) across the Company’s manufacturing location ensuring compliance to and continuous improvement of the Quality Management System. This leader will be expected to apply his/her knowledge of Quality Assurance and Quality Control principles and techniques to positively collaborate and lead in in the advancement and effective operation of the QMS. In parallel, the candidate shall also ensure QA/QC personnel are adequately trained and developed to advance the business objectives of the Company.

Responsibilities

• Manages various QC/QA program(s)/processes within the department and the manufacturing location (training, nonconformance management, CAPA, supplier quality, data review and reporting, etc.) and serves as subject matter expert (SME).
• Coordinates and facilities QC/QA activities to meet commitments on-time.
• Ensure QC/QA personnel have appropriate training and competency.
• Leads planning, coordination and/or review of test method validations, test method transfers and/or equipment qualification/requalification, as required.
• Assist in troubleshooting of test methods and/or equipment as required.
• Authors, review, and/or approves data, SOPs, COCs, DHRs and other documents as needed.
• Monitor, track publish and report QC/QA metrics (NCMR, CAPA, etc.) at the Operations meetings. As necessary analyze QC/QA metrics to identify trends and actions necessary to correct adverse trends.
• Ensure all QC/QA records and DHR documentation adhere to cGMP/GDP expectations.
• Leads compliance related teams working towards the goal of continuous improvement.
• May be required to lead NCMR, OOT investigations/deviations and to identify corrective actions to prevent reoccurrence.
• Integral part of Plant Leadership team and serves as QC/QA representative in cross-functional, cross-departmental working teams.
• Participates in internal and external quality audits.
• Defines appropriate measures to ensure product and process quality.
• Recruits, coaches, and develops organizational talent.
• Defines appropriate measures to ensure product and process quality.
• Maintains knowledge of current regulatory requirements and standards as they pertain to the development and release of product, particularly medical devices.
• Travel requirements: 25% including international travel.

Job Qualifications/Requirements:

• Bachelor’s degree (B.S.) in an Engineering, Technical, or Scientific field
• Minimum of 8 years of relevant experience, or advanced degree with minimum of 6 years relevant experience
• Minimum of 2 years of managerial experience.
• Experience leading or supporting FDA inspections and ISO 13485 audits.
• Good knowledge of risk management processes (system risk analysis, DFMEA, PFMEA)
• Prior experience working in medical device industry and with product submissions to regulated bodies (e.g., FDA) preferred
• ISO 13485 Leader Auditor, preferred.
• Project Management skills preferred.
• Commitment to excellence and high standards
• Excellent written and oral communication skills preferred.
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
• Acute attention to detail
• Demonstrated ability to plan and organize projects
• Ability to work independently and as a member of various teams.
• Proven ability to manage multiple projects and meet deadlines.
• Ability to develop clear, concise, and timely oral and written reports.
• Accurately complete detailed forms and reports.

Bachelors