Supplier Quality Engineer
Company: Exactech, Inc.
Location: gainesville
Posted on: May 3, 2021
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Job Description:
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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