Senior Quality Specialist (On-site)

We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients’ smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future for ZimVie — we hope you’ll consider being a part of it!

Location:

This position is based in San Antonio, Texas.

Job Summary:

This position provides oversight for the remediation, development, and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and ensures that the performance and quality of processes conform to established internal and external standards and guidelines. Takes on Quality projects of low to moderate complexity as assigned.

Principal Duties and Responsibilities:

• Provides oversight for the implementation and maintenance of quality systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance
• Works directly with business partner to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Generates Quality monthly KPI metrics and facilitates CAPA Trigger and Management Review Meetings.
• Perform procedure updates as required. Submit Document Change Requests related to process improvements and/or Procedure Periodic Reviews
• Management of NC, CAPAs, Complaints, incident reporting, QMS.
• Work with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities and lifecycle management.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personnel and Company compliance with all Federal, State, local and Company regulations, policies, and procedures (FDA Part 820, ISO-13485, Part 11, etc.)
• Perform other duties and manages projects assigned as needed

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

• Ability to define problems, collect data and analyze data, establish facts, and draw conclusions and recommendations.
• Experience with QMS and validated software
• Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
• Leads quality systems projects.
• Ability to deliver, meet deadlines and have results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.
• Experience with Microsoft Office Suite products
• Project Management training and/or experience
• Working understanding of 21CFR, 820, 803, Part 11, etc. associated to the manufacturing, design and distribution of medical devices coming from a dental lab
• Requires ability to work onsite in San Antonio, Texas
• CQA and/or Lead Auditor certification (Preferred)

Education/Experience Requirements

• Typically requires a B.S. in engineering or an alternative Bachelor’s degree program
• A minimum of 5 years of quality, design quality, complaints, process, software validation and/or quality systems experience in the medical device industry.
• Certification as a quality auditor (e.g. CQA) or Lead Auditor preferred but not required.
• Combination of education and experience may be considered (in evaluating experience relative to requirements)

Travel Requirements

               Up to 5%

#LI-Onsite

ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, demotion, evaluation, compensation, and separation, are considered without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender/sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state and local laws.

ZimVie generally does not sponsor applicant work visas for this position.

• Requisition ID: 3164