POSITION SUMMARY
This position reports directly to the Site Quality Lead with a dotted line to the Zoetis Global Quality Systems & Standards (QSS) Lead and will serve as the most senior QSS personnel for the Site. Together, with the department colleagues, they will serve as a partner alongside other stakeholders to enable the Site to meet its Quality objectives and ultimately the overall Site objectives. The QSS Engineer will be the Site Owner of the Quality Management System (QMS) and Supplier management program. They will be responsible for the execution of all quality related governance aspects for Quality (QA and QC) and Operations at the site. The QSS Engineer will have overall responsibility to assure that the Site is compliant and aligned with Zoetis Global QSS. The QSS Engineer will lead the Quality System & Standards for the Site, assuring compliance with ISO 9001 or other pertinent regulations along with Supplier management process. This individual will be responsible for Systems, Standard Operating Procedures and Tools to be in place and in use as well as being properly maintained. Through the Key Quality Performance Indicator Dashboard, the Engineer will monitor Site quality systems performance and facilitate appropriate metrics and communications. The QSS Engineer is responsible for Continuous Improvement activities through participation in the Site Quality Council as well as administration of the Site Quality Road Map.
POSITION RESPONSIBILITIES
Key objectives of this position include:
1) Implement QMS elements compliant to ISO 9001.
2) Apply the Zoetis Global Quality Standards and Systems and tools at the Site. Maintain the Site QSS in a state of compliance with all applicable Regulations.
3) Develop and use effective monitoring and controls for key processes and product quality - providing assurance of continued suitability and capability of processes.
4) Monitor site Quality System performance through established key quality performance indicators (KPI).
5) Facilitate site management review process to ensure the effectiveness of the site management review. assess the quality systems' continued suitability and effectiveness.
6) Conduct Site's Quality Council.
7) Provide specific Site Wide data integrity (DI) awareness and training on an annual basis.
8) Lead Site's Supplier management program
9) Ensure GMP documentation is properly managed and archived.
10) Assure the use of operational excellences tools in quality procedures and processes.
11) Support the development of Quality Goals and targets as part of the organization's strategic plan.
ORGANIZATIONAL RELATIONSHIPS
The QSS Engineer will interact regularly with Site Leadership to assure quality goals and objectives are met.
Additionally - the Engineer will work closely with the Corporate QSS Leader to stay current with all Zoetis QSS practices, systems, and strategies. Other key associations will be with certain members of VMRA and GQCA.
EDUCATION AND EXPERIENCE
•Undergraduate degree in engineering, or chemistry sciences.
•Relevant advanced degree preferred.
•5 years relevant experience in Medical Device/In Vitro Diagnostics and Animal Health industry
•Working knowledge/fluency of Quality Management Systems, ISO 9001.
TECHNICAL SKILLS REQUIREMENTS
•Ability to lead a site quality systems and compliance organization.
•Driven / Passionate about Quality performance and delivering results.
•Sets Clear Direction and Aligns Team and Others Around Common Objectives
•Ability to influence peer in implementing QMS system.
•Inspires Continuous Improvement and Breakthrough Thinking
•Exercises Good Judgment and Drives Change - using appropriate influence techniques.
•Strong written and oral communication skills
•Proficient in English
•Demonstrated skills in presenting to leadership teams.
•Business Fluency and Ability to be a Trusted Partner.
PHYSICAL POSITION REQUIREMENTS
•Durham, North Carolina Site based position
•This position will require fluent use of teleconferencing and Zoom tools, as well as SharePoint technologies, to share and manage information with Global Quality Centre Organization and other Zoetis internal manufacturing network.
Full time
Regular
Colleague
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