At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Principal Product Supply Quality Engineer

Principal Product Supply Quality Engineer

PURPOSE

The Principal Engineer - Product Supply Quality Engineering is a key member within our Radiology Sterile Disposables team and is responsible for quality engineering aspects of medium to high complexity manufacturing projects that deploy new assets into various manual and automated manufacturing operations across multiple supply centers (domestically & internationally). Specifically, this position will lead all quality engineering activities related to the design, development, commissioning, qualification, and validation of new production equipment and processes - in support of new product launches, production volume increases, and site-to-site technology transfers.

YOUR TASKS AND RESPONSIBILITIES

Serve on Manufacturing Science & Technology project teams as the lead ambassador for the Plant Quality Assurance Teams, ensuring that all new equipment, processes, and quality controls meet the needs of the manufacturing operations, customers, and regulators while fulfilling all internal and external GxP requirements;

• Ensure all new equipment, processes, quality controls, and documentation are stable, capable, defendable, and human-useable before launch;
• Facilitate the development of and own the creation of all quality engineering documentation such as PFMEAs, MVPs/MVRs, PCPs, etc., and other deliverables as assigned by project teams;
• Provide all quality engineering content needed as input for various project documentation such as Manufacturing Plans/Schedules, URSs, FRSs, Trace Matrices, etc.;
• Approve all GxP relevant documentation generated by assigned project teams;
• Guide the project team development of IQ, OQ, PQ, SWV, TMV, and other protocols;
• Guide the project team designs of new Test Methods and Test Method Validation strategies;
• Ensure suitable, adequate, and effective application of all validation strategies, capability studies, and statistical methods by the project teams;
• Facilitate all GMP reviews and process governance activities;
• Provide regular knowledge sharing and training to plant quality engineers and technicians to enable successful launches;
• Lead / Support cross-functional team investigations by conducting problem solving and root cause analysis to address failures identified throughout the development to launch process;
• Understand and apply knowledge of product line and clinical applications to work activities, in support of new manufacturing process development and/or new product development;
• Provide technical leadership and mentorship to the Project Teams you serve and to the Quality Engineering Team in which you report;
• Manage complex, quality-driven process improvement initiatives focused on the commissioning, qualification, validation, and technology transfer processes.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• Bachelor’s degree in engineering, science, or related discipline;
• Progressive experience in a technical role within a medical device (or similar high-quality conscious) business;
• Considers interpersonal and communication skills a personal strength, including a knack for effectively collaborating with and influencing individuals;
• Natural leadership style with an ability to share technical and project management experience;
• Direct experience with the application of at least some quality engineering, risk management, and statistical technique tools such as D/PFMEA, GR&R, DOE, PCP, and/or Acceptance Sampling;
• Comfortable and confident in quickly comprehending critical topics, discerning best next steps, and guiding the team toward effective solutions;
• Trustworthy ability to empathize with diverse perspectives across different organizations and cultures while fostering win-win solutions;
• Passion for managerial courage and ability to challenge the status quo consistently and respectfully;
• Willing to travel domestically and internationally as required (<20%).

PREFERRED QUALIFICATIONS

• Ten (10) years of progressive experience within the medical device or other highly regulated industry;
• Master’s degree (and 6 years of experience) or PhD degree (and 4 years of experience) in engineering, science, or related discipline;
• Direct experience with the quality engineering aspects of new product introduction, manufacturing technology development, automated assembly development, technology transfer, and/or core manufacturing operations;
• A thought leader in the development of efficient and effective process controls – from risk identification and analysis to robust process control planning to lean quality control & test development to production floor implementation and training;
• Direct experience with the commissioning, qualification, and validation of manufacturing processes and the HW & SW that enable them (ex. C&Q, DQ, IQ, OQ, PQ, SWV, TMV, PV, etc.);
• Direct experience with automated assembly of complicated disposable medical devices;
• Direct experience with technical process development and technical procedure writing;
• Direct experience with Quality Management System (QMS) process development and QMS procedure writing;
• Auditing experience and strong understanding of at least one QMS standard such as 21CFR820, ISO 13485, ISO 9001, AS 9100, and/or IATF 16949;
• Experience and understanding of ISO-14971, ISO-11607 and ISO-10993;
• Lean Six Sigma certified Blackbelt.