Job Information
AbbVie Quality Engineer - Medical Device Design Control (all genders) (permanent / full-time) in Ludwigshafen, Germany
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The job that makes possibilities real in patients' lives. And yours.
The job that helps you get ahead in life. Moving mountains together.
Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? You’ve come to the right place!
Moving mountains together – as Quality Engineer - Medical Device Design Control (all genders) (permanent / full-time)
You will be primary responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations.
Your responsibilities:
Perform QA activities related to Combination Product and Medical Device Development:
Ensure compliance with company policies and procedures.
Perform design control and risk management activities according to AbbVie's Quality System
Partner within Quality and R&D to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
Perform 3rd party supplier management activities such as review 3rd party design control activities
Support the creation of regulatory submission documentation
Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure
Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions
Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents
Apply knowledge of global regulations, guidance's, and Corporate and Function standards
Lead/assist in the preparation of and support regulatory agency and internal audits
Qualifications
Qualifications:
Bachelor’s degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area
4+ years of industry experience in Quality Assurance, Development or healthcare related field. Less experience considered with advanced degree. Medical device experience required. Combination Product and 3rd party supplier management experience desired
Strong understanding of regulations and standards affecting combination products and medical devices
Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills
Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management
Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues
Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities
Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required
Capable of clearly presenting and justifying quality requirements to management
Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)
Here's how we can move mountains together:
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
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 as at TalentAcquisition.de@abbvie.com – we look forward to hearing from you!
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.