QA Manager - Manufacturing - Frankfurt Main - mfd
QA Manager - Manufacturing - Frankfurt Main - mfd
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Salary Not Disclosed
1 Vacancy
Job Description
The QA Manager Manufacturing is responsible for all Quality related activities compliance to Sirtex QMS and applicable global regulations and Quality team members located at the manufacturing facility in Frankfurt.
- Manage lead and direct the efforts of the Frankfurt site Quality team members to ensure that manufacturing related processes and activities comply with the applicable global medical device regulations (e.g. FDA EU etc) and Sirtex Quality Management System requirements.
- Host and lead internal and external audits of the manufacturing facility and manages followup actions as required.
- Participate and deploy products or process changes at the manufacturing facility ensuring compliance to global medical device regulations and Sirtex Quality Management System requirements.
- Collaborate with other functional teams to identify investigate and resolve product quality issues in a compliant and effective manner.
- Manage select train and develop staff as well as conduct performance reviews and performance management activities.
- Ensure compliant investigations are conducted in a timely manner and in accordance with medical device regulations and Sirtex Quality Management system.
- Participate in supplier qualification audit ongoing monitoring and supplier improvement activities.
- Develop and deploy Quality System related processes tools training and metrics to enable Sirtex to meet business needs and comply with global medical device regulations.
- Lead CAPA post market surveillance and other quality improvement efforts at the manufacturing site.
- Provide key quality trending information and data for use in periodic reviews.
- Apply sound systematic problemsolving methodologies in identifying prioritizing communicating and resolving quality issues.
- Use statistical tools to analyze data make acceptance decisions and improve process capability (Six Sigma SPC DOE).
Qualifications :
- Minimum of 7 years Manufacturing Quality experience and minimum of 3 years of supervisor or leadership experience within Medical Device industry or Pharmaceutical/biotech.
- Bachelors degree required preferably in Engineering or Science.
- Demonstrable competency with the Medical Device Regulation 2017/745 21 CFR 820 EN ISO 13485 an EN ISO 14971 particularly with respect to Quality responsibilities associated with manufacturing related activities.
- Prior leadership as SME during internal and external audits.
- Demonstrable competency in developing and implementing QMS procedures compliant with medical device regulations such as FDA 21 CFR MDR 2017/745 EN ISO 13485 etc.
- Demonstrable competency and prior experience conducting internal audits supplier audits and supplier qualification activities.
- Experience with the EU MDR regulation and Post Market Surveillance requirements.
- Strong English and German written and verbal communication and presentation skills.
- Competent in Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).
- Ability to prioritize focus collaborate and work effectively in a fast paced and dynamic cross functional environment.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
This is an onsite role at our Frankfurt Facilities in FrankfurtHchst. If you are interested please apply with a motivation letter and CV in English and German
Do you want to be part of something bigger A team whose impact stretches across the globe making a real difference to the quality of peoples lives. Sirtex recognizes that wellbeing financial health and worklife balance are crucial for our employees to achieve personal success.
Sirtex offers qualified candidates:
- Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
- A culture of respect diversity collaboration and innovation fostering inclusiveness and superior performance.
- Attractive compensation and benefit packages which are practical robust and equitable.
- A commitment to support ongoing professional growth through career development on the job experiences and training opportunities.
- Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
- An unwavering commitment to company values employee safety and excellence in everything we do.
Diversity drives innovation; inclusion fosters belonging growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement teamwork and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued included and can share their ideas so that we can exceed even our own expectations.
Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or veteran status age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
