Quality Manager - Medical Device

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.

Education and/or Experience:
• Bachelor degree or equivalent, previous experience preferred

Language Skills:
• 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.

Reasoning Ability:
• 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.

Computer Skills:
• Proficient in all Microsoft Office applications (Word, Excel, Outlook)

Physical Demands:
The physical demands described here are 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. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit. Specific vision abilities required by this job include ability to adjust focus.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.






ADDITIONAL NOTES
ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis.
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.
A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.