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Job Responsibilities and Essential Duties:
Develops and manages the department to assess and ensure compliance with
- FDA Quality System Management Regulations (QMSR) CFR Part 820,
- ISO 13485:2016 (Medical Device QMS Standard),
- ISO 9001:2015 (Quality Management Systems, Requirements)
- EU Medical Device Regulation (MDR), (Regulation (EU) 2017/745),
- Health Canada-Canada Medical Devices Regulations (CMDR) (SOR/98-282)),
- Therapeutic Goods Administration (TGA)-Australian Medical Device Regulations (TG(MD)R 2002),
- UK-Medicines & Healthcare products Regulatory Agency (MHRA) (UK MDR 2002 (as amended)),
- and other applicable global regulations as needed to support global portfolio expansion.
- This position is responsible for maintaining the Quality Management System, Internal Audit program, GetQMS Implementation, OneDoc/TrackWise Digital, GetLearning, and all Corporate OneTrack processes (complaint, CAPA, HHE, field actions), Management Review, Monthly metrics meetings, Quality planning, management of 3rd party audits (FDA, ISO, other), FDA inspection response to 483 observations, and periodic updates. This position partners with SWICC Regulatory and QRC leaders as well as representatives/leaders from other cross-functional groups on Quality Management System improvements. The position will manage a local quality team.
- The position will lead the quality compliance team and coordinate activities to effectively maintain the quality system in accordance with the applicable regulations and standards.
- Lead the implementation and ongoing effectiveness of the Quality Management System (QMS) at the Healthmark site in alignment with corporate standards and applicable global medical device regulations.Direct day-to-day Quality Compliance activities in support of business objectives, including oversight of CAPA processes and follow-up effectiveness; management of Internal Audits, complaints, nonconforming material (NCR) processes, and supplier quality controls; facilitation of Management Review and monthly QMS metrics monitoring to ensure visibility to compliance risks; and leadership of Quality Planning activities to ensure effective implementation.
- Act as the site Management Representative, ensuring QMS suitability and effectiveness, including facilitation of Management Reviews per corporate requirements.
- Perform the role of Person Responsible for Regulatory Compliance (PRRC) as mandated by EU MDR 2017/745, Article 15.
- Provide Quality review and approval, as appropriate, for change notices, including both design and document changes, ensuring compliance with applicable regulatory requirements, quality system procedures, and change control processes.
- Lead and manage all external regulatory inspections and third-party audits (e.g., FDA, Notified Bodies, MDSAP, Health Canada, TGA, MHRA), including end-to-end inspection readiness activities, front-room and back-room coordination during inspections, and post-inspection response execution. Responsibilities include inspection preparation, hosting and facilitation, real-time issue escalation, development and submission of responses to observations (e.g., FDA Form 483, audit nonconformances), and oversight of corrective and preventive actions through to closure.
- Maintain compliance with 21 CFR 820, 803, 806, ISO 13485, ISO14971, and other applicable standards.
- Management of compliance with applicable External Standards and worldwide regulations.
- Manage departmental costs and spending in support of business objectives.
- Develop and maintain a competent and accountable organization that is positioned to support and accomplish business objectives while maintaining compliance with applicable standards, laws, and guidance.
- Ensure that all Quality Management System processes are in compliance with external and internal GMP requirements and provide quality compliance to support operational objectives and customer requirements..
- Strengthen quality awareness, support technical services, and process improvements.
- Responsible for investigating, identifying, and implementing best-in-class Quality Compliance practices across SWICC.
- Build effective cross-functional partnerships and establish credibility with internal and external stakeholders to support business objectives and compliance performance.
- Works collaboratively with internal functional departments (Quality Assurance, Regulatory Affairs, R&D/Engineering, Purchasing, Sourcing, and Operations, others) to accomplish business objectives while maintaining compliance with applicable standards, laws, and guidance.
- Guides Technical Oversight on Design Control, Manufacturing QA, and Supplier Quality
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Required Knowledge, Skills and Abilities:
- Demonstrated leadership, problem-solving, decision-making, influencing, facilitation, and communication skills, with the ability to engage effectively at all organizational levels.
- Must have the ability to assess the impact of quality management strategies on business performance.
- Must have in-depth knowledge of all applicable Quality and Regulatory standards
Minimum Requirements:
- A Bachelor’s Degree in Engineering, Science, or other related field (or related work experience) is required. A Master’s of Science (or related field) or MBA is a plus. ASQ, CQE, greenbelt or other applicable certifications are a plus.
- A minimum of seven-ten (7-10) years of experience in quality assurance, quality compliance, or related functions in an FDA-regulated industry and/or ISO certified organization managing FDA Class II (or Class III), and EU MDR Class I/IIa/b devices is required.
- Ten to fifteen (10-15) years of related experience managing quality systems and implementing Quality Management systems in the medical device, pharmaceutical, or related industry is preferred.
Quality Requirements:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
- Attend all required Quality & Compliance training at the specified interval.
- Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
Environmental/Safety/Physical Work Conditions:
- Ensures environmental consciousness and safe practices are exhibited in decisions
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments
- May work extended hours during peak business cycles
- 4-day-a-week requirement on-site in Fraser, MI
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
$162,000-$202,000/annually + 13% STIP
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