At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward.
As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world.
To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards.
We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.
**What You Can Expect**:
- The QARA Specialist, as part of the EMEA Quality Commercial & Distribution Team within the Commercial Organization, will be responsible for supporting the Quality Assurance & Regulatory Affairs function of the assigned region.
Ensure compliance with the requirements of ISO 13485 Quality Management System, appropriate company policies and any other ISO if applicable or required in country (i.e ISO9001, ISO14001, ISO37001 e.t.c).
Ensure that local organization comply with industry specifications, standards and European as also in country regulations (i.e European Medical Device Regulation (EU) 2017/745).
**How You'll Create Impact**:
Quality Management System (QMS) Implementation
- Support implementation, development, maintenance, and improvement of the local QMS (Quality Management System), according to international standards and corporate guidelines/policies/procedures, as per instructions of the direct manager.
- Ensure awareness about QMS across the local organization Zimmer Biomet LRD.
- Drive CAPAs and Issue Evaluations as per the internal procedures.
- Participate and provide support,to the Management Review Meetings, Risk Management Reviews, Supplier Review Boards, Distributor Review Board, CAPA Review Board meetings and other QMS relevant, if applicable to the assigned region
- Support his/her team and QA/RA EMEA with QA/RA standardization of processes.
- Work on continuous improvement of our processes, where applicable and if needed.
- Where applicable, plan, support and join the internal and external audits in assigned region as appropriate; also, within an internal auditor team coordinated by headquarters (if applicable).
Ensure the Audit preparation activities and support for auditees.
Ensure follow-up on Audits (Internal/EMEA/External) as appropriate and required by the internal procedures.
All as per instructions of the direct manager.
- Ensure continuous communication, reporting and escalations to QA/RA manager/supervisor, and QA/RA EMEA as per the need and the instructions of the direct manager.
- Support to QA/RA Manager and other colleagues in QA/RA team if needed.
**What Makes You Stand Out**:
- Organized: Ability to handle high volume of correspondence and prioritize work accordingly
- Autonomous: Ability to work independently and collaboratively in a team-oriented environment.
- Methodical: Ability to prepare high quality, clear communication materials to the appropriate audience
- Excellent communication and interpersonal skills.
- Detail-oriented: with a commitment to accuracy and precision.
- Diplomatic and tenacious.
- Discretion and confidentiality
- Fluent in English
**Your Background**:
- B.S.
or M.S.
degree in biomedical/clinical engineering, pharma, biological or medical science or equivalent experience required.
- 2+ years' experience in registration/notification activities and/or quality assurance in medical devices, pharma, or veterinary area.
- English language is a basic requirement, high standard of English speaking-writing skills.
- Strong knowledge of ISO standards (ISO13485, ISO9001), and other relevant regulatory requirements.
- Knowledge of USFDA and European Medical Device Regulations (i.e EUMDR 2017/745) and local applicable regulations.
- Deep knowledge of regional/in-country Medical Device legislation.
- Experience with Windows Office Software, especially Excel and Power Point, SAP.
EOE/M/F/Vet/Disability