Quality Engineer II - NPI (On-site)

ZimVie US Corp LLC

  • Palm Beach Gardens, FL
  • Permanent
  • Full-time
  • 15 days ago
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!Job Summary:The New Product Introduction (NPI) Quality Engineer is responsible for supporting the design, development, and processing of medical implants and instruments, focusing on both new product development and the maintenance of existing products. As a core team member, this role leads development efforts, ensuring that quality standards are integrated from concept through commercialization. The position addresses moderately complex, varied, and routine quality engineering challenges requiring analysis of diverse data and factors. The engineer exercises sound judgment within defined procedures, contributing technical expertise to investigations, risk assessments, and process improvements. Responsibilities include ensuring product compliance through audits, inspections, and testing activities. The role involves collaboration across multiple departments, external suppliers, and subject matter experts to achieve organizational quality goals. The engineer builds effective relationships to resolve cross-functional challenges, provides standard professional guidance, and develops initial analyses and reports for team review. This role plays a key part in aligning product development activities with regulatory requirements and internal quality policies.Principal Duties and Responsibilities:
  • Maintain adherence to ISO 13485, ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), EU MDR, and 21 CFR Part 820 requirements throughout the product lifecycle.
  • Lead and support design control activities including design input/output, design verification/validation, and design transfer in compliance with applicable standards and company procedures.
  • Develop and maintain risk management files per ISO 14971.
  • Collaborate with cross-functional teams to ensure biocompatibility requirements are met per ISO 10993.
  • Apply Quality Engineering tools and statistical methods (e.g., DOE, SPC, Six Sigma) to support NPD, process optimization, and root cause analysis.
  • Lead Design for Manufacturability (DFM), inspect ability, and cost-effectiveness initiatives.
  • Write, review, and/or approve IQ/OQ/PQ, process validation, Test Method Validation (TMV), software validation, and equipment qualification protocols and reports in alignment with FDA and ISO expectations.
  • Utilize Root Cause Analysis (5 Whys, Fishbone, etc.) to implement effective Corrective and Preventive Actions (CAPAs).
  • Perform and analyze Gage R&R studies. Recommend or validate inspection methods.
  • Perform Installation Qualification (IQ) for inspection equipment and support review of OQ/PQ.
  • Initiate and manage Document Change Requests (CRs). Update procedures as needed, supporting periodic reviews.
  • Generate and maintain Design History Files (DHF), Device Master Records (DMR), and technical documentation in compliance with EU MDR Annex II & III.
  • Compile and present monthly quality KPIs to management. Drive data-based decisions to support continuous improvement.
  • Interface with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to align quality goals and ensure successful product launches.
  • Coordinate product evaluations with dental professionals and surgeons.
  • Contribute to generation and review of design assurance documents, including risk assessments, technical files, and validation plans.
  • Prepare new or revised product specifications, perform stress analysis, and manage prototype development.
  • Ensure personal and company-wide compliance with all federal, state, local, and company policies and regulations.
  • Communicate business-related issues and opportunities to appropriate levels of management.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.Expected Areas of Competence (i.e., knowledge, skills, and abilities)
  • A minimum of 2 years of quality, design quality, complaints, Supplier Quality and/or manufacturing engineering experience in a medical device, pharmaceutical, and/or biopharma industry.
  • Ability to define problems, collect data and analyze data, establish facts, and draw conclusions and recommendations.
  • Knowledge in understanding blueprint/drawing/ and/or GD&T.
  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
  • Facilitates team efforts on quality engineering 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.
  • Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, PFMEA, and product testing methods.
  • Knowledge of statistics, process control, and process capability.
  • Requires ability to work in office at least 4 days a week.
Education/Experience Requirements
  • B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE) is preferred but not required.
  • Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred but not required.
  • Minimum 2 to 4 years’ experience in a Quality Engineering role, or an equivalent combination of education and experience.
  • Combination of education and experience may be considered (in evaluating experience relative to requirements)
  • CQE and/or Green belt certification (Preferred)
  • Experience with Minitab software (Preferred)
  • Six sigma and/or knowledge of Process Excellence tools (Preferred)
  • Experience with ISO 13485 quality management systems.
Travel Requirements
  • Up to 5%
#LI-OnsiteZimVie 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: 3100

ZimVie US Corp LLC