1. Knowledgeable in FDA 21CFR Part 820 regulations and ISO-13485.
2. Must adequately represent Exactech and Exactech QA processes while helping to build Exactech-supplier cross functional partnerships.
3. Assumes an active role by facilitating selection, development, qualification, approval and monitoring of suppliers
4. Leads as supplier liaison with internal customers to ensure effective problem resolution of supplier quality issues
5. Lead supplier audits, supplier visits, and coordinates / leads supplier conference calls
6. Lead or participate in development or continuous improvement projects focused on supplier quality
7. Identify supplier non-conformance (NPR) trends, provide technical support on NPR investigations, follow-up on associated actions, and work cross-functionally to establish relevant inspection and test procedures
8. Actively involved with Purchasing and QA on tracking quality performance of product and service suppliers
9. Actively involved in establishing Quality Agreements and/or Exactech-Supplier Terms & Conditions (T&Cs) in collaboration with suppliers
10. Lead justification and rationale for supplier-based Deviation Requests for process and product deviations
11. Actively involved in Supplier CAPAs
12. Actively involved in First Article Inspection (FAI) program, including establishing requirements, facilitating completion of associated activities, and review and approval of FAI results
13. Actively involved in the development of metrics, reports, and management review presentations (as needed)
14. Able to support verification and validation activities through IQ, OQ, and PQ protocol development and execution.
15. Actively involved in gathering, monitoring, and reporting of Supplier related CAPA triggers
16. Assist and support other team members as necessary.
Education: Bachelor’s Degree from an accredited institution required; Master’s Degree preferred
• Minimum 5-7 years of experience in Supplier Quality Management and the medical device industry or other regulated industry (Automotive, Aerospace)
• Strong working knowledge of quality systems and risk management (ISO 13485, ISO 17025, ISO 14971, 21 CFR Part 820, Part 11)
• Demonstrated ability to understand technical drawings and Geometric Dimensioning and Tolerancing (GD&T)
• Working knowledge of process and product validation (IQ, OQ, PQ)
• Demonstrated understanding of Failure Mode and Effects Analysis (Design & Process)
Functional / Technical Knowledge, Skills and Abilities Required:
• Demonstrated understanding of Statistical Techniques, including Statistical Process Control (SPC) and experience implementing SPC or similar controls
• Ability to work effectively in a team environment
Competencies: to be completed by Human Resources. Core:
Work Standards Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
Decision Making Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
Managing Work (includes Time Management) Effectively managing one's time and resources to ensure that work is completed efficiently.
Planning and Organizing Establishing courses of action for self and others to ensure that work is completed efficiently.
Building Strategic Work Relationships Developing and using collaborative relationships to facilitate the accomplishment of work goals.
Energy Consistently maintaining high levels of activity or productivity; operating with vigor, effectiveness, and determination over extended periods of time.
Type ONE ‘X’ for each Activity to indicate the appropriate Physical Requirements:
Limited travel or overnight
Occasional travel or overnight
Frequent travel or overnight; including international
Normal or corrected vision and hearing x
Normal or corrected vision and hearing
Normal or corrected vision and hearing
Can distinguish varying or specific colors, patterns or materials
Understand, speak, read and write basic English x
Understand, speak, read, and write fluent English
Understand, speak, read and write fluent English
Understand, speak, read and write fluently in a foreign language
Physical Activity x
Lift approximately 0-25 lbs.
Use of fine motor hand functions Lift approximately 25-50 lbs.
Use of fine motor hand functions Lift approximately 50+ lbs.
Use of fine motor hand functions
Typically in a consistent temperature
Occasionally exposed to varying degrees of hot and cold environments
Frequently exposed to varying temperatures from below 32 degrees to above 80 degrees
Operating Room Entry x
Typically in office environment without a need to enter the OR
Infrequent entry to the OR. No credentialing required.
Frequent entry to the OR.
Must be able to clear all credentialing and vaccination requirements
Valid Driver’s License x
Helpful but not required
Required for position
Type ONE ‘X’ for each Activity to indicate the appropriate Environmental Considerations:
Typically not in a manufacturing environment, no special safety considerations Typical manufacturing environment
Safety glasses required
Typical manufacturing environment
Safety glasses required
Steel Toed shoes required
Blood borne Pathogens X
No risk of exposure Limited risk of exposure to blood borne pathogens
Likely exposure to blood borne pathogens
No risk of exposure
Limited risk of exposure to hazardous chemicals
Exposure to hazardous chemicals
Bachelors or better in Accounting.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)