Senior Quality Assurance Engineer

2 weeks ago

Palm Beach Gardens, Florida, United States ZimVie Full time

At ZimVie, we are a publicly traded, global leader in life sciences dedicated to enhancing the daily lives of our patients through the innovative design, manufacturing, and distribution of a wide range of tooth replacement and spine surgery solutions. Our foundation is built on a legacy of trusted brands and clinical evidence, fostered by an inclusive and collaborative culture that encourages our team members to bring their authentic selves to work every day, striving to fulfill our Mission. Our diverse global team is shaping an exciting future, and we invite you to consider joining us.

Key Responsibilities:

  • Developing, maintaining, and optimizing controlled technical documentation, including prints, procedures, bills of materials, and routers.
  • Conducting feasibility studies on advanced processes to estimate product costs and assess capital equipment, capacity, and capability needs.
  • Establishing and refining process methodologies that meet performance and quality standards.
  • Leading qualification and validation projects for quality and manufacturing equipment.
  • Tackling complex product, quality, and process performance challenges.
  • Creating justifications for establishing new performance and quality benchmarks.
  • Employing Quality Engineering tools and processes to effectively develop, transfer, and maintain products and processes throughout their lifecycle.
  • Executing Gage R&Rs related to inspection methods and proposing new or alternative inspection techniques to enhance quality and reduce inspection time.
  • Updating procedures and submitting Document Change Requests related to process enhancements and periodic reviews.
  • Collaborating with other departments, including R&D and Operations, to support new product development, engineering initiatives, quality assurance efforts, and lifecycle management.
  • Drafting, reviewing, and approving validation protocols and reports, equipment qualifications, engineering change orders, Test Method Validations (TMV), and software validations.
  • Utilizing statistical tools to analyze data, make acceptance decisions, and enhance process capability (including Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE)).
Required Competencies:
  • In-depth understanding of mechanisms necessary for implementing processes and managing product flow.
  • Comprehensive knowledge of development processes and procedures.
  • Ability to lead and prioritize medium complexity project assignments while ensuring timely completion.
  • Capability to define problems, gather and analyze data, establish facts, and formulate conclusions and recommendations.
  • Proficiency in working within a team environment and building relationships across departments and with external stakeholders (suppliers, regulatory agencies, etc.).
  • Strong foundation in statistics, process control, and process capability.
Education and Experience:
  • Bachelor's degree in mechanical, industrial, or related engineering field, or an equivalent program with certification as a quality engineer (e.g., CQE) is preferred.
  • A minimum of 5-8 years of experience in manufacturing engineering.
  • Familiarity with Lean Principles and/or Six Sigma or other problem-solving methodologies is preferred.
ZimVie is an Equal Opportunity Employer committed to fostering 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.

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