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Supplier Quality Engineer

Company: Exactech, Inc.
Location: gainesville
Posted on: May 3, 2021

Job Description:

Duties and Responsibilities (Key Deliverables):

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.

Job Requirements:

Education: Bachelor's Degree from an accredited institution required; Master's Degree preferred

Experience: 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.

Functional:

Physical Requirements:

Type ONE 'X' for each Activity to indicate the appropriate Physical Requirements:

ACTIVITIES ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS

Mobility x Frequent sitting

Limited standing, walking, climbing, crouching, bending, pushing, or pulling Occasional sitting

Occasional standing, walking, climbing, crouching, bending, pushing, or pulling Limited sitting

Frequent standing, walking, climbing, crouching, bending, pushing, or pulling

Travel x Limited travel or overnight Occasional travel or overnight Frequent travel or overnight; including international

Visual/Hearing Normal or corrected vision and hearing x Normal or corrected vision and hearing

Not colorblind Normal or corrected vision and hearing

Not colorblind

Can distinguish varying or specific colors, patterns or materials

Language 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

Environment x Typically indoors

Typically in a consistent temperature Occasionally outdoors

Occasionally exposed to varying degrees of hot and cold environments Frequently outdoors

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 Not required Helpful but not required Required for position

Environmental Considerations:

Type ONE 'X' for each Activity to indicate the appropriate Environmental Considerations:

ACTIVITIES ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS

Safety X 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

Chemical X No risk of exposure Limited risk of exposure to hazardous chemicals Exposure to hazardous chemicals

Keywords: Exactech, Inc., Gainesville , Supplier Quality Engineer, Other , gainesville, Florida

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