Are you an experienced Quality Executive within the Medical Device Industry?
We have a great opportunity for you! The Director of Quality Management establishes, manages, coordinates, and evaluates the activities of Quality System and regulatory compliance programs. Oversees the development and field performance of medical products in compliance with corporate policies. Oversees quality metrics with a focus on root cause investigations and prevention of problems. Leads and monitors in achieving a culture of continuous improvement. Management of and participation in the Corporate Internal Audit program covering all domestic sites including planning, coordination and follow-up on global audits according to group directives and procedures.
The Quality Manager will be part of the strategic executive leadership team with directly report to the COO.
• Develop, deploy and maintain a Company-Wide Integrated Quality System in accordance with applicable local ordinances, State statutes and Federal regulations, and other laws, including FDA’s 21 CFR, FDA QSR, ISO13485, Canadian Regulations, etc. and company requirements.
• Effectively lead a multi-member team inclusive of Technical, Regulatory Agency and Radiation Safety experts while assisting COO in driving accountability and ownership of the QMS to department managers and employees.
• Assures global and local QS and procedures for regulatory compliance are established and driven into the culture of this organization. Periodically reviews the suitability and effectiveness of the quality system with executive management.
• Interacts frequently with all levels of management and cross functions. Adept in driving initiatives locally while coordinating efforts globally within the wider corporate structures.
• Develops and implement an effective Quality System Integration Management program
• Assist each facility in the development of the site Quality (Integration) Plan
• Develops, implement and maintain an effective and compliant program in: Document Management, Monitoring and Trending, CAPA, Risk Management, Systems Validation, and Employee Training
• Ensures CAPA Review Board (CRB), Field Action Determinations (FAD) are effectively documented and communicated to relevant functions. Ensure risk management files are utilized, updated and kept current
• Ensures all remediation from internal and external audits are promptly addressed
• Performs trend analysis of quality data associated with all products and recommend corrective/preventive actions for problem resolution. Analyze processes, work operations, quality records, complaints, and other sources of data to identify existing and/or potential causes of failures. Where failures and potential failures are identified, investigate and assist in making recommendations necessary to correct and prevent recurrence
• Manages and operates as company leader in all FDA, ISO and Regulatory audit activities
Requirements include (you must have ALL for consideration):
• Requires extensive independent decision making ability and applying regulations and standards (ISO, QSR, etc.) governing the manufacturing and distribution of medical devices
• Understand interactions and interdependency of elements within the quality system in a medical device manufacturing organization
• Full working knowledge and experience with all development procedures and processes, including design control and FOCUS process
• Must have a thorough knowledge of ISO, QSR and other relevant FDA requirements as applied to medical device development, manufacturing and quality
• Strong knowledge of FDA QSR, CFRs, ISO13485, Canadian, Mexican, and device & drug regulatory requirements and of standard quality assurance practices for manufacturing operations such as the ISO 9001, ISO14971, etc. and FDA requirements, Document Control, Statistics, SPC, GD&T, Sampling, DOE, APQP, PPAP, FMEA, MSA, SPC) is required
• Minimum 8 years’ experience establishing and maintaining quality systems in the Medical Device industry
• Bachelor’s and/or Master Degree in a Scientific or Engineering discipline is required
• Professional quality discipline certifications (CQE, CQA, CQM or RAB) is desired
• Experience navigating new products through the FDA approval process
• Expertise in gaining FDA recertification
• Previous management /supervision QA/QE/QC
• Experience with Lean Manufacturing and Six Sigma is a plus
• Regulatory experience including 510K is desired
$110,000 – $120,000 Base with a $140,000 – $160,000 total package
For consideration, submit your resume to MDiSabato@Morisey-Dart.com