Senior Manager Quality Assurance
Senior Manager Quality Assurance
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Salary Not Disclosed
1 Vacancy
Job Description
JOB DESCRIPTION:
Thoratec Switzerland GmbH is part of the medical device division of Abbott Laboratories a fortune 500 company with over 115000 employees worldwide. We are the global market leader for implantable and extracorporeal blood pumps based on magnetic levitation technology. Our life-saving systems which we develop and manufacture in Zurich are used for advanced heart failure patients needing short- or long-term circulatory support.
Our location in the heart of the city of Zurich has around 130 employees in the areas of development quality and production of the CentriMag system and the HeartMate 3.
Are you a strategic leader passionate about quality innovation and making a difference in healthcare Join our Zurich team asSenior Manager Quality Assurance where youll lead with purpose foster collaboration and shape the future of our quality systems in a dynamic and inclusive environment.
Position Overview
As theSenior Quality Manager Quality Assurance for our Zurich site youll be the key point of contact for all quality-related matters including interactions with external regulators and Notified Bodies. Youll lead the development and execution of our sites Quality strategy ensuring alignment with global standards and business goals while championing continuous improvement and operational excellence.
This role offers a unique opportunity to influence site-wide strategy guide cross-functional teams and support the expansion of manufacturing capabilities including clean room processes. Youll work closely with senior leadership and empower a talented team to deliver high-quality safe and compliant products that improve lives.
Key Responsibilities
Compliance & Regulatory Leadership
Serve as the Quality Management Representative for the Zurich site and manufacturer of the Centrimag product line.
Ensure compliance with global quality system regulations (USA EU Korea Brazil Australia Canada Ukraine Switzerland).
Lead site readiness for inspections and audits and represent the facility during regulatory and internal audits.
Team Leadership & Development
Lead and mentor a diverse team across operations quality regulatory compliance supplier quality and new product development.
Foster a culture of inclusion collaboration and continuous learning.
Identify and manage resource needs to support operational excellence and future growth.
Quality Systems & Process Excellence
Oversee quality system processes including document control CAPA risk management supplier evaluations and complaint handling.
Support centralized functions like Regulatory Affairs and vigilance reporting with timely and accurate data.
Drive improvements through data analysis and quality management reviews.
Product Acceptance & Customer Safety
Own final decisions on product quality and release ensuring compliance and customer protection.
Manage non-conformance evaluations and ensure timely resolution aligned with patient safety.
Strategic Planning & Budget Management
Plan and manage the Quality department budget in alignment with business objectives.
Collaborate with Finance Site Director and divisional leadership to ensure responsible and strategic resource allocation.
Cross-Functional Collaboration
Partner with Operations R&D and external stakeholders to resolve quality issues and support product development.
Contribute to Zurich site strategy and support the integration of new manufacturing processes.
Qualifications What Will Help You Thrive in This Role
AMasters degreein Science Engineering or a related technical field with10 years of experiencein the medical device industry.
At least5 years of leadership experiencein a quality systems environment ideally within medical devices.
Strong understanding ofISO standardsand global regulatory frameworks (e.g. US EU) related to medical devices.
Proven ability tolead and inspire teams with a focus on coaching development and inclusive leadership.
Comfortable using business and technical software tools; open to learning new systems.
Strong analytical and decision-making skills with a collaborative and solution-oriented mindset.
Excellent communication skills in English with German proficiency considered an asset for engaging a broad range of stakeholders.
Able to work independently and collaboratively acrossglobal teams including remote sites.
Highly organized with strong time management and prioritization abilities.
Skilled in building relationships and navigating complex environments with empathy and professionalism.
Committed to ethical standards and delivering high-quality outcomes.
Working at Abbott
At Abbott you can do work that matters and help people to live a healthier and fuller life grow your career and learn be your true self. You will have access to:
Career development with an international company where you can grow
A workplace in a fortune 500 company and the worlds leading manufacturer of medical devices
A challenging position in a crisis independent industry
To become part of a dynamic highly educated highly skilled and motivated team
Multi-national environment where we foster the development of our talents within theenterprise
Competitive compensations and benefits
A workplace in the heart of Zurich
Please follow our Career site and check for available openings:
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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 20 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Senior Manager
Employment Type
Full-Time
