Danaher Corporation Quality Assurance Analyst - CAPA Coordinator (f/m/d) in München, Germany
Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. At first glance, you’ll see we are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Look again and you’ll see we are invested in you and you’ll have the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Do you want to provide quality assurance services to ensure the integrity of our products? We are seeking a multifaceted, experienced Quality Assurance Analyst, with a focus on CAPA coordination, to join our team in Munich! This role has a primary focus of managing process and product non-conformances in line with company procedures, conduct quality assurance tests to ensure product specifications are met, and review, investigate, resolve and report on quality discrepancies. The ideal candidate will serve as a subject matter authority and will lead audit and inspection preparation and take ownership for the resolution of audit and inspection findings.
Responsible for CAPA Management activities include but are not limited to the monitoring of information relative to problem statements, root cause analysis, corrections, corrective and preventative actions, tracking of time lines, and establishing CAPA files.
Monitor the effectiveness of the CAPA system.
Coordinate all needed training for users of the CAPA system.
Serve as the Local coordinator of the CAPA meetings.
Trend CAPA metrics and present defined reports at specified intervals. Present CAPA information during Management Reviews.
Assist/Interface with CAPA owners on CAPA Investigations and Action Plans.
Support or Conduct training on CAPA tool usage SMARTSOLVE
Responsible for Local CAPA activities.
Support CRB Manager in the effective implementation of CAPA Process across sites.
Bachelors or Master´s degree in Engineering Field (Mechanical or Electrical Engineering field or any other relevant Engineering fields).
Experience in Non-conformance / Deviation / CAPA Management.
Experience in implementation of Good Documentation Practices, 21 CFR Part 11.
The following are an added advantage:
Sound knowledge of regulatory requirements for Medical Device Quality Management – ISO 13485, ISO 14971, 21 CFR Part 820, IVDD / IVDR
Language skills – Proficient spoken and written English skills. German is an advantage.
Soft skills – Independent, organized, tenacious, team-work oriented, problem-solving mindset.
Experience in Pharmaceuticals may be considered on individual case basis.
Modern, virtual working approach in an exciting international environment.
Locations in the beautiful Munich area, close to public transportation.
Flexible working hours and hybrid working where possible.
Regular career and development cycles as well as salary reviews and a bonus system.
Active Diversity & Inclusion Council to ensure an inclusive work environment, equal opportunities and pay.
Company Pension Plan.
Contribution to the costs of the job-ticket of the public transportation of Munich.
Development: Danaher is a company that believes in continuous improvement — it is at the core of how we lead and operate our businesses. Whether refining our processes, our tools, or our products, the theme of evolution and getting better is fundamental to our DNA.
When you join the team, we will support your early days with a structured onboarding plan and a peer will support you throughout the onboarding phase. You are not left alone.
By joining Beckman Coulter, you will have access to our great internal training courses and be part of our Development for Growth Program.
You will also enjoy the advantages of the internal job platform, Danaher Go.
Well Being Program: We want you to be at your best both on and off the job. This means not only rewarding you for your contributions to our organization, but also providing the support you need to live a happy, healthy, fulfilling life outside of work.
Should your life get out of balance, the free Employee Assist Program (EAP) is available to you in the areas of questions about handling stress, maintaining relationships, dealing with work-related issues, coping with loneliness and improving communication.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.