Quality Manager - Medical Device

ARCH•Emerson, NJ

About The Position

Responsibilities of essential functions include: 1. Appointed Management Representative 2. Lead, coordinate, author and review regulatory filing documents 3. Prepare US FDA submissions and CE Mark technical documentation files, including 510(k) submissions, Device Master files, technical files and post market surveillance for product changes and/or new products as required to ensure timely clearance or approvals 4. Collect documentation and coordinate with cross-functional teams to prepare regulatory submissions to regulatory agencies 5. Create and maintain regulatory submission timelines and track deliverables to ensure company goals are met 6. Develop and execute company’s regulatory strategy in the US, EU, Canada and other international markets 7. Provide strategic input and regulatory advice to project teams and development programs including new product development and changes to existing products 8. Keep abreast of current regulatory landscape for medical devices globally, e.g. FDA guidance documents, EU MDR, EU guidance documents, etc. 9. Develop and communicate recommendations regarding new/emerging regulations to management and project teams 10. Represent the company and work directly with regulatory authorities on regulatory issues and submissions 11. Provide in-house training on quality/regulatory related issues 12. Support international RA and QA efforts and collaborate with other teams across the company as needed 13. Manage and modify a complete and comprehensive quality management system for class I, II and higher medical devices 14. Review quality system processes to improve awareness, visibility and communication on quality initiatives to support assigned quality goals and objectives 15. Conduct onsite audits and host regulatory agency audits as needed 16. Evaluate, author and review SOPs, Forms, Work Instructions, etc. 17. Handle customer related quality issues Responsibilities of non-essential functions include: 18. Prioritize daily tasks resulting in “on-time“ processing 19. Establish and maintain an import and export compliance program 20. Assist Marketing with trade show related shipping/receiving tasks 21. Direct and assign tasks to Quality/Shipping/Receiving/Warehouse/Repairs personnel 22. Recommend and implement measures to motivate employees to improve operation methods, equipment performance, product quality or efficiency 23. Recommend personnel actions such as hiring, promotions, firings, evaluations and conflicts 24. Perform physical inventory checks with Purchasing 25. Observe and monitor gauges, dials and other indicators to ensure that operators conform to SOPs 26. Perform all aspects of building management including safety and sanitation regulations 27. Maintain commitment to Quality Goals and Quality Policy 28. Complete jobs and tasks as assigned Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements

Bachelor degree or equivalent, previous experience preferred
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to write speeches and articles for publication that conform to prescribed style and format.
Ability to effectively present information to top management, public groups, and/or boards of directors.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Proficient in all Microsoft Office applications (Word, Excel, Outlook)

Responsibilities

Appointed Management Representative
Lead, coordinate, author and review regulatory filing documents
Prepare US FDA submissions and CE Mark technical documentation files, including 510(k) submissions, Device Master files, technical files and post market surveillance for product changes and/or new products as required to ensure timely clearance or approvals
Collect documentation and coordinate with cross-functional teams to prepare regulatory submissions to regulatory agencies
Create and maintain regulatory submission timelines and track deliverables to ensure company goals are met
Develop and execute company’s regulatory strategy in the US, EU, Canada and other international markets
Provide strategic input and regulatory advice to project teams and development programs including new product development and changes to existing products
Keep abreast of current regulatory landscape for medical devices globally, e.g. FDA guidance documents, EU MDR, EU guidance documents, etc.
Develop and communicate recommendations regarding new/emerging regulations to management and project teams
Represent the company and work directly with regulatory authorities on regulatory issues and submissions
Provide in-house training on quality/regulatory related issues
Support international RA and QA efforts and collaborate with other teams across the company as needed
Manage and modify a complete and comprehensive quality management system for class I, II and higher medical devices
Review quality system processes to improve awareness, visibility and communication on quality initiatives to support assigned quality goals and objectives
Conduct onsite audits and host regulatory agency audits as needed
Evaluate, author and review SOPs, Forms, Work Instructions, etc.
Handle customer related quality issues
Prioritize daily tasks resulting in “on-time“ processing
Establish and maintain an import and export compliance program
Assist Marketing with trade show related shipping/receiving tasks
Direct and assign tasks to Quality/Shipping/Receiving/Warehouse/Repairs personnel
Recommend and implement measures to motivate employees to improve operation methods, equipment performance, product quality or efficiency
Recommend personnel actions such as hiring, promotions, firings, evaluations and conflicts
Perform physical inventory checks with Purchasing
Observe and monitor gauges, dials and other indicators to ensure that operators conform to SOPs
Perform all aspects of building management including safety and sanitation regulations
Maintain commitment to Quality Goals and Quality Policy
Complete jobs and tasks as assigned