Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
For the EMEA production plant, based in Winterthur (Switzerland), we are looking for a:
The Regulatory Compliance Senior Manager is responsible for coordinating and developing processes and systems for key quality system elements. Utilizes appropriate tools to develop effective strategies to improve the performance of the quality system. Develops relationships with key stakeholders to identify needs. Resolves complex problems that have implications beyond own area. Requires professional expertise and interpersonal skills to manage multiple projects and interface with personnel from all company disciplines and business units. Takes accountability, achieves results and develops self and others.
Your main responsibilities:
- Hires, trains, develops, and manages the Regulatory Compliance team
- Responsible for development and oversight of departmental goals and projects
- Process and Data Owner for Document / Change Control, Training, Archiving and Audits
- Develops and implements quality system strategies and objectives
- Develops metrics for determining effectiveness the quality system and develops plans to address
- improvements as identified
- Identifies quality system issues and improvements and works with various operational groups to create
- plans to resolve and implement
- Maintenance and optimization of the quality management system
- Coaches process owners in process improvement
- Supports the Management Review
- Leading and assisting Quality Planning projects & CAPA projects
- Leading and assisting Risk Management and PMS processes
- Coordination of training needs with other Managers / Supervisors
Your Qualifications and Experience:
- Degree in business or engineering or professional experience in a similar position
- Quality Systems Manager training with Diploma examination or equivalent experience
- Lead Auditor training with Diploma examination or equivalent experience
- Knowledge / background in medical device industry
- Must be knowledgeable and stay current in the regulatory requirements for key quality system elements to maintain compliance and drive improvements needed to support business needs
- Knowledge of applicable Regulations and Standards, in particular ISO 13485, ISO 14971, the Medical Device Directive 93/42/EEC, Medical Device Regulation (EU) 2017/745, US Quality System Regulations 21 CFR 820, MDSAP and other relevant Country Regulations
- Must be able to balance priorities among many ongoing tasks, and be responsive to critical situations
- Must have excellent written and oral communication skills in German and English and exhibit organized work habits and the ability to be detail oriented when required
- Must be able to work with all levels of employees, including hourly production employees through senior management
- Leadership skills including effective employee selection, development and motivation along with performance management
- Managing projects and processes
- Cross Boundary teamwork
- Strong customer focus
- Ability to train personnel
- Ability to question established processes, to make proposals for improvement
This dynamic Job position has a willingness to travel from 5%.
If you seize this opportunity, you will be able to develop your international experience and be a part of a great and truly global team.Zimmer offers a wide range of challenging career advancement opportunities and a dynamic work environment. We look forward to receiving your complete application.
Zimmer Switzerland Manufacturing GmbH
Frau Julia Kues-Schnell
Human Resources Senior Generalist