Lead, Quality Control

Lead, Quality Control

As one of the world´s leading manufacturers of cardio
- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Lead, Quality Control (QC) is responsible for the supervisory of inspection team, to achieve the quality objectives, operational targets, and product quality requirement. The role will be supporting and driving compliance/continuous improvements of incoming, in-process and final acceptance quality performance. He/She shall be responsible to collaborate with the relevant cross functional departments/functions, for alignment and maintain product quality management.

**Your Responsibilities**
- Manage and lead the QC Inspection team to achieve the product quality performance and operational goals.
- Deploy the inspection resources productively to support the operational requirements.
- Ensure that the Inspection team complies with all quality system procedures and inspection requirements.
- Lead the Inspection team to support the achievement of Quality, Operation and Continuous Improvement goals.
- Collaborate with quality engineering team to establish incoming inspection, requirements and metrology requirements for new product/raw components.
- Monitor the Inspection team's performance and take relevant actions to address issues.
- Responsible for the staffing, training and development of the Inspectors to ensure a competent workforce.
- Interface with various cross functional teams in problem solving and participate in Corrective Actions activities.
- Demonstrate personal commitment to Quality, meeting all Quality and regulations requirement. Driving the quality culture within the team.
- Partnering with engineers and technicians to address quality related operations activities, including testing at In-coming, In-processes and Final acceptance to ensure that products comply with quality standards, per BIOTRONIK specifications.
- To develop and manage a team of QC inspectors. Provide guidance, coaching and support to the Quality Control team on responsibility, project assignments, improvements project and initiatives.
- Provides leadership and coaching to all direct reports, includes performance assessment & individual development plan establishment.
- To provide key performance metrics updates to management.
- Support and Execute projects/task and any others quality related activities as directed by supervisor.

**Y**our Profile**
- Technical/Scientific degree at college/University level
- At least eight years’ of relevant experience in a supervisory capacity, preferably in quality function under regulated environment (medical devices/life science/pharmaceutical industry)
- In depth know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, or applicable local regulations.
- The ability to foster a productive team-oriented environment, handling multiple assignments, and flexibility in responding to an environment with rapidly priorities shifting/changes is preferred.
- Well-developed problem solving skills, excellent verbal and written communication skills, and the ability to listen, learn, teach, and think strategically are traits that are required for long term success in this role.
- Technical knowledge and experience to work effectively with cross functional teams. (Operations, R&D, Facility Management, HR, Procurement, Finance), is preferred.
- Documents and Records lifecycle management experiences, is preferred.
- Good communication skills with people from all levels in the organization
- SAP and Success Factor User experience is a plus

**What we offer**
- being encouraged to think and act entrepreneurially
- working in global teams and projects
- developing yourself professionally

Location: Singapore | Working hours: Full-time

Job ID: 51580 | Contact: Human Resources

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.