Manager Quality System & Regulatory Compliance
Share
Job Location:
Zürich - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Thoratec Switzerland GmbH part of Abbott Laboratories is a global leader in implantable and extracorporeal blood pump systems. Our lifesaving medical devices developed and manufactured at our Zurich site support patients with severe heart disease worldwide.
Our Zurich team of approximately 150 colleagues brings together expertise across R&D manufacturing quality and regulatory functions. As we continue to expand our innovative and high-impact work we are looking for an experienced Manager Quality System & Regulatory Compliance who is motivated by purpose collaboration and continuous improvement.
The Role
In this role you will shape and strengthen our Quality Management Systems while leading and developing a team of Quality System specialists. You will work closely with colleagues across Operations R&D Engineering and Regulatory Affairs to ensure our products and processes meet the highest regulatory and quality standards always with patient safety at the center.
This position offers the opportunity to combine people leadership strategic influence and hands-on quality expertise in a global regulated medical device environment.
What Youll Do
Lead & Inspire
Lead support and develop a team of Quality System specialists setting clear goals aligned with company objectives and regulatory requirements
Foster a collaborative inclusive and accountable team environment
Support performance development through coaching feedback and training
Quality & Compliance Leadership
Ensure effective execution and continuous improvement of the sites Quality Management Systems
Maintain compliance with applicable international standards and regulations (e.g. ISO 13485 FDA QSR EU MDR)
Prepare and support the site during external audits and regulatory inspections (e.g. FDA Notified Bodies)
Act as a key quality partner for Operations R&D Engineering and Regulatory Affairs
Continuous Improvement & Problem Solving
Identify opportunities to improve processes compliance and efficiency across the organization
Lead or contribute to global quality improvement initiatives
Own and drive corrective and preventive actions (CAPA) including root cause analysis and sustainable solutions
Collaboration & Communication
Operate effectively in a matrixed international environment
Build trusted relationships with global and regional stakeholders
Communicate clearly and confidently across technical and nontechnical audiences
Your Expertise
Required
Masters degree in science engineering or another relevant technical discipline
35 years of experience in quality systems within the medical device industry (or similarly regulated environment)
Strong working knowledge of ISO 13485 FDA 21 CFR Part 820 EU MDD/MDR MDSAP
Experience leading teams or guiding others in a regulated setting
Strong communication skills in English and German
What Helps You Succeed
You balance attention to detail with a pragmatic solutionoriented mindset
You enjoy developing people and helping teams perform at their best
You are comfortable influencing in a matrix organization
You value high ethical standards and taking ownership
I
f you dont meet every requirement but believe this role is a strong fit for your experience and aspirations we encourage you to apply.
What We Offer
Meaningful work that directly impacts patient lives
A stable and growing company in a resilient industry
A collaborative respectful and international working environment
Flat hierarchies with open and transparent communication
Opportunities for personal and professional development within Abbott
A modern workplace in the center of Zurich with R&D and manufacturing on site
Ready to Apply
We look forward to receiving your application (CV and motivation letter in PDF format). All qualified applicants are encouraged to apply we value diversity and believe it strengthens our teams and our impact.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
HF Heart Failure
LOCATION:
Switzerland : Technoparkstrass 1 CH 8005
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 10 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Key Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
