Medical Device Quality Assurance Specialist

hace 1 día

Valencia, Valencia, España Zimvie Us Corp Llc A tiempo completo

We are ZimVie, a leading global life sciences company focused on 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.

Job Overview

As a Medical Device Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards in our manufacturing processes. This role requires strong analytical and problem-solving skills, as well as excellent communication and collaboration abilities.

Key Responsibilities
  • Support the validation activities related to facilities, equipment, processes, and computer systems as established in the internal procedures of the Quality System.
  • Coordinate and conduct preventive and corrective actions (CAPAs), product controls, process and system changes (Engineering Change Request - ECRs and DCRs) from the perspective of Quality Assurance and carry out derived actions.
  • Participate in production transfer projects (Transfer-in Transfer-out).
  • Make modifications and updates to internal documents as a consequence of the implementation of global procedures and other changes.
  • Participate in projects for the industrialization of new products and processes.
  • Take part in OPPs (Operating Project Plan) and Lean Manufacturing projects.
  • Conduct product non-conformities, process, and quality system according to internal procedures.
  • Review product reprocesses (reworks and revisions).
  • Control equipment out of specifications, according to internal procedures.
  • Take part in the development of Quality Holds and product quarantines.
  • Generate control plans and guidelines for different products and processes.
  • Write and run TMVs (Test Method Validations).
  • Manage temporary authorizations (TAs) and interim controls (ICs).
  • Collaborate in PFMEAs investigations (Process Failure Mode Effects and Analysis) and document DMRs (Device Master Records).
  • Analyze deviations of manufactured products.
  • Provide data for indicator reports for Quality Assurance activities.
  • Carry out internal audits of the Quality System and participate in external audits.
Requirements
  • The ideal candidate should meet the requirements for this role, with at least 2 years of experience in a similar position, especially in manufacturing and a multinational environment.
  • BSc in Engineering (Industrial, Mechanical, Organizational); BSc in Biology, Health Science, Chemistry, or other related field.
  • Master's degree in Quality Management is an asset.
  • Proficiency in Spanish and English, both verbal and written.
  • Deep understanding of manufacturing processes and methods, quality management (ISO 9001) and Lean Manufacturing tools (Six Sigma, Kaizen, Kanban, 5S...).
  • Knowledge of statistics and specific medical regulations (ISO 13485, EU MDR 2017/745, 21 CFR FDA) is desirable.
  • Good computer skills, including proficiency with MS Office tools.
  • Excellent planning, detail-oriented, organization, and prioritization.
  • Ability to make decisions, analysis, and problem-solving.
  • Ability to build strong relationships with other areas of the company and ability to influence others.
  • Strong attention to details and multitasking.
What We Offer

Zimvie Us Corp Llc offers a competitive compensation package, including a salary range of $60,000-$80,000 per year, depending on experience. Additionally, we offer a permanent contract, meal allowance, private life, health, and dental insurance, learning & development program, and a challenging position with good career prospects in an international medical device business.

This position is required in Valencia, Spain. If you are interested in this opportunity, please apply online enclosing your cover letter, CV, and references via our homepage.

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