Career Opportunity
Senior Manager, Quallity Operations
Category
Manufacturing
Location
El Paso, Texas
Salary
$120,000 - $140,000
Job Reference
53726
Senior Manager, Quallity Operations
Job Purpose:
Oversight of Quality Operations activities (Quality Assurance & Quality Control) across the Company’s manufacturing locations 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 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 Responsibilities:
- Oversee diverse QC/QA programs and processes across manufacturing sites, including training, nonconformance management, CAPA, supplier quality, and data analysis, serving as a subject matter expert.
- Coordinate and facilitate QC/QA activities to ensure timely delivery on commitments.
- Ensure QC/QA staff receive adequate training and maintain competency levels.
- Lead, coordinate, or review test method validations, transfers, and equipment qualifications as needed.
- Provide support in troubleshooting test methods and equipment malfunctions.
- Author, review, and approve various documents including data reports, SOPs, COAs, and DHRs.
- Monitor and report QC/QA metrics such as NCMR and CAPA, analyzing trends and implementing corrective actions as required.
- Ensure all QC/QA records and DHR documentation meet cGMP/GDP standards.
- Lead compliance-focused teams aimed at continuous improvement.
- Lead investigations into NCMRs, OOT deviations, and develop preventive actions.
- Act as a key member of the Plant Leadership team and represent QC/QA in cross-functional collaborations.
- Participate in both internal and external quality audits.
- Define strategies to uphold product and process quality standards.
- Recruit, mentor, and develop talent within the organization.
- Stay updated on regulatory requirements and standards relevant to product development and release, particularly in the medical device sector.
- Expected travel: 25%, including international trips.
Job Qualifications:
- Bachelor’s degree (B.S.) in Engineering, Technical, or Scientific discipline.
- Minimum of 10 years of relevant experience, or 8 years with an advanced degree.
- At least 4 years of managerial experience.
- Experience in leading or supporting FDA inspections and ISO 13485 audits.
- Proficient in risk management processes such as system risk analysis and DFMEA.
- Previous involvement in the medical device industry and familiarity with product submissions to regulatory bodies (e.g., FDA) is preferred.
- Preferably certified as an ISO 13485 Leader Auditor.
- Strong project management skills are advantageous.
- Demonstrates commitment to excellence and high standards.
- Excellent written and verbal communication skills.
- Strong organizational, problem-solving, and analytical abilities.
- Capable of managing priorities and workflow efficiently.
- Adaptability to work within dynamic environments and changing priorities with enthusiasm.
- Exceptional attention to detail.
- Demonstrated ability to plan, organize, and execute projects effectively.
- Capable of working independently and collaboratively in various team settings.
- Proven track record of managing multiple projects and meeting deadlines consistently.
- Ability to generate clear, concise, and timely oral and written reports.
- Proficient in accurately completing detailed forms and reports.
IND123
Job Purpose:
Oversight of Quality Operations activities (Quality Assurance & Quality Control) across the Company’s manufacturing locations 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 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 across manufacturing locations (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, COAs, 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 10 years of relevant experience, or advanced degree with minimum of 8 years relevant experience
- Minimum of 4 years of managerial experience.
- Experience leading or supporting FDA inspections and ISO 13485 audits.
- Good knowledge of risk management processes (system risk analysis, DFMEA)
- 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
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