Quality Manager II, Combination Products & Medical (all genders) (fulltime, regular)

• Assure proper integration and support of device, drug and biologics regulations.
• Lead product team members through the design process providing guidance while working closely with research organizations to ensure potential product issues are identified and addressed to ensure robust product requirements.
• Ensure design control documentation as well as design change control requirements are met by assessing the impact of a change on the safety, efficacy of the combination product/device.
• Perform 3rd party supplier management while reviewing and approving supplier design control activities, assess supplier changes, provide input to quality agreements, and maintain appropriate balance between internal oversight actions and supplier controls.
• Partner with third party vendors, manufacturers and laboratories to ensure that combination products/devices follow internal and regulatory agency standards, including supplier site visits and support of supplier audits.
• Foster close global collaboration with R&D, Operations and Commercial Operation functions to identify and mitigate product risks while performing risk assessment of changes on safety and efficacy, utilizing risk control tools such as FMEA.
• Identify gaps in existing processes as well as the need for new processes in the cross-functional collaboration.
• Guide project development in global and local product development teams to proactively address quality-related issues, advise internal business partners and cross-functional groups on QA expertise as well as medical device/combination product regulations.

Qualifications

• Bachelor's degree in biomedical engineering, mechanical engineering, or another relevant technical or scientific discipline.
• Minimum 6+ years of industry experience in Quality Assurance, development or healthcare related field. Medical device experience required. Combination Product and 3rd party supplier management experience preferred. Less experience considered with advanced degree.
• Understanding of regulations and standards affecting combination products and medical devices required. Must have negotiation skills and have been seen to take a position on Quality issues and standards and must be capable of clearly and logically justifying such positions.
• Sound technical understanding of product development (e.g. approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control.
• Well-versed in risk management methodologies and their application.
• Able to take the initiative to identify and implement new approaches to resolve problems, able to challenge scientific arguments - strong analytical approach to identify problem areas and effective solutions.
• Work independently and in a global team environment, and with all levels of personnel within the organization.
• Excellent knowledge of the English and the German language (spoken and written).

• with a diverse work environment where you can have a real impact
• with an open corporate culture
• with an attractive salary
• with an intensive onboarding process with a mentor at your side
• with flexible work models for a healthy work-life balance
• with a corporate health management that offers comprehensive health and exercise programs
• with company social benefits
• with a wide range of career opportunities in an international organization
• with top-tier, attractive development opportunities
• with a strong international network

At multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) - a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect. At AbbVie, your individual contributions count - help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV - we will discuss everything else with you in person. Any questions? Feel free to email us at TalentAcquisition.de@abbvie.com - We are looking forward to hearing from you!

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html