Senior DQA Manager-Shanghai

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

The Design Assurance Quality Manager will be a part of the Quality organization, lead and manage of the design assurance quality team in China to support division NPD and sustaining R&D activities, together with China local projects.

The individual will demonstrate a primary commitment to patient safety and will be responsible for collaborating with cross-functionals. The individual will be responsible for assuring all requirements for the Product Development Process (PDP), Risk Management, Design Controls, Verification and Validation Testing, and External Manufacturer Production Controls are met by: a.) Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design & Development Plan, Product Specification, Test Methods, Design Review, Design Verification & Validation (V&V), Usability Testing, Software Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured,  b.) Leading the execution of quality deliverables such as Risk Management Plan/Report, Hazard Analyses, Use and Design FMEA, Usability Testing, Quality Plans, and Field Assessment Plans, c.) Providing quality and compliance input and coaching for product development, and d.) Supporting Corporate Quality initiatives utilizing their PDP, Risk Management, and Design Controls expertise.

The individual should be a team player who is willing to collaborate and work in cross functional teams across geographies and cultures and should be comfortable working in a matrix organizational structure.

• Be a part of core project team and lead the quality engineering across the entire development cycle. Ensure compliance with the laws and regulations of the targeted market for distribution, quality systems design control requirements and Boston Scientific’s PLCP.
• Lead the development and implementation of design verification and validation plans with project design lead.
• Lead product usability and design validation efforts for new product development and design change projects.
• Lead risk management activities throughout the product lifecycle.
• Responsible for co-leading design reviews, design change with R&D team.
• Partner with process development engineers to design transfer to manufacturing.
• Provide product specific supplier and co-development quality assurance expertise during supplier audits, and through approval of supplier PDP and Design Controls deliverables.
• Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).
• Manage the team of quality assurance on meet the above requirements, together with people development, performance management and resource planning.
• Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
• Participate and support ISO13485 Certification and MDSAP for the R&D center.
• Carry out other reasonable tasks as required by the Line Manager.
• The above duties and responsibilities are not an exhaustive list, and the individual may be required to undertake any other reasonable duties compatible with experience and competencies. This description may be varied from time to time to reflect changing business requirements.

• Bachelors (or higher) degree in engineering with preference mechanical engineering, electronics and embedded systems, plastics and polymer engineering and biomedical engineering.
• 8+ years of experience in medical device R&D quality engineering, systems and / or quality engineering supporting R&D projects, design assurance and documentation.
• Professional training and understanding in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation.
• Sound understanding of medical device regulatory requirements for Class II and III medical devices.
• Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
• Past experience as a design engineer will be an added advantage.
• Experience of establishing and promoting a work environment that supports the Quality Policy and Quality System is a plus.

• Excellent Communication, presentation and interpersonal skills with proficiency in English (verbal and written).
• A positive attitude, innovative and creative thinker.
• Responsible risk taking and risk management.
• Experience in working with global and virtual team and working in a cross cultural environment.

Requisition ID: 621958

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!