Danaher Corporation Senior QA Specialist in Stargard, Poland
Radiometer, part of the American corporation Danaher, is a world leader in the development, production and distribution of technologically advanced blood analyzers in the field of gasometry, electrolytes and metabolites. There are two production plants in Stargard that deal with the production of accessories for Radiometer devices, where they are assembled, among others, syringes and electrodes, employing nearly 800 people. In connection with the vacancy - we are looking for candidates for a position in the QA (PPV/VAVE) department.
Are you interested in making a difference in the Medical Device industry?
Are you focused and proactive?
Then we have the job for you! With reference to the QA Sr. Manager of Validation & ECO and a dotted line to QA Sr. Manager in Poland, you will join a team of high skilled, enthusiastic colleagues in a dynamic company. The department is QA responsible for Process Validation, Software validations, Test method validations, ECO systems and cost projects (PPV) support to production and R&D.
Your responsibility will be mainly QA support to Production projects and changes, especially PPV/VAVE Projects. You will be part of the established PPV team.
Your main responsibilities and tasks will include:
QA support in relation to Projects (PPV and VAVE)
Ensure regulatory compliance in PPV/ VAVE projects
Supervision in preparation and approval of documentation related with process validation/revalidation activities
Supervision in preparation and approval of documentation related with software validation/revalidation activities
Supervision and support on risk analysis in relation to material/supplier changes
Support and facilitate the preparation of MPS documents in relation to PPV and VAVE
Support and facilitate the preparation of design control documentation in relation to PPV and VAVE
Approval and support of change control activities in relation to PPV and VAVE
Assure effective cooperation and collaboration within the project team on a daily basis
Support other projects and activities in QA area
We expect that you have a master's degree in engineering. Perhaps within Production or Quality Management, or another degree combined with experience from manufacturing industry, medical devices or pharma.
This combined with most of the following skills and experiences increases your chances of success in the job:
+7 years of experience in QA (medical devices and pharma preferably).
Experience with ISO13485:2016 and QSR Part 820 and Part 11.
Experience with process validation and re-validation.
Experience with SW validation and re-validation.
Experience in engineering change processes.
Understanding and experience in risk analysis process.
Experience in design control activities.
Knowledge and experience in Project Management.
Good Leadership skills in a Global environment.
Fluent Polish and English, both writing and oral
Traveling between 14-20% of time per year post-COVID can be expected (mainly to Denmark).
An outstanding opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Poland and abroad we have hardworking colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer 'freedom with responsibility', flexibility, opportunities for training and career development, and a wide range of staff benefits.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .