Senior Quality Manager, Design Transfer

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Senior Quality Manager, Design Transfer position will have responsibility for the design transfer of all Diabetes Care Blood Glucose Monitoring Systems (strips, meters & accessories), FreeStyle Libre portfolio of products, medical device combination products, new medical sensors, Lingo which will deliver products to over 15MM customers globally over the next 5 years with a revenue of over $10Bn.

In addition, this position will also be accountable of transfer of all designs (new product introductions, product changes to on market products, test method validations, complaint investigation techniques) into all manufacturing sites, including contract manufacturers.

What You’ll Work On

• Provides quality oversight in specific areas of subject matter expertise in the transfer of all new products and product changes from R&D into Manufacturing Operations including completion of commercialization activities to launch new products according to division goals. Works within areas of subject matter expertise, but sets broader strategy and decisions on what directions to take for the assigned elements of the project.
• Develop with minimal supervision, implement and improve quality processes and procedures, automated systems and reporting systems across areas of expertise and those connected processes.
• Assesses the Quality System of Contract Manufacturers, identifies gaps and develops action plans to address the gaps. Executes to the plan.
• Support the development of program strategies for product transfer. Interference as needed with R&D to Manufacturing Operations, Quality and other cross functional leadership for product transfer and change management.
• Supports continuous product and process improvement through mitigations of identified site quality risks and product quality metrics.
• Work effectively with other departments, especially engineering teams, to define requirements and drive quality excellence of products, including design documents review, processes/practices simplification, QMS training, etc.
• Ensures that product validation and design activities are handled in a manner that complies with all pertinent regulatory requirements. Serves as the subject matter expert on validation processes for with external manufacturing partners.
• May manage Quality Engineers, providing mentoring, technical guidance and career growth planning.
• Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts.
• Decision and recommendations made by this position have a direct impact on marketed items for domestic and international sales.
• Assure line of communication with Director of Design Transfer on critical quality issues that may result in potential business interruption.
• Approver of change control process to assess and implement changes to DMR documents associated with design transfer activities.
• Facilitates discussions and manages the commercialization of TPM manufactured materials required for the product.
• Works with R&D and Operations to develop and implement a manufacturing validation strategy and address equipment, process, and test method validations required for product transfer.
• Approver of the validation master plan.
• Recognizes the impact and interconnections in the organization and/or system, develops and recommends alternatives that support project strategies.
• Requires a high level of independence and excellent interpersonal and communication skills.
• Prepare and present written and oral reports and other presentations to internal and external audiences, including senior management.

Required Qualifications

• Bachelors Degree or Masters Degree preferred.
• Minimum of 7+ years of progressive work experience in a Medical Device company.

Preferred Qualifications

• Regulatory Knowledge: Understanding and complying with regulatory requirements (e.g., FDA, ISO 13485) is critical to ensure that the products meet all necessary standards and can be marketed legally.

• Technical Expertise: A deep understanding of the technical aspects of medical device design, manufacturing processes, and validation methods is necessary to oversee the development and transfer processes effectively. Typically a subject matter expert in Validation along with other Quality System Subsystems.
• Quality Control and Risk Management: Implementing robust quality control measures and risk management strategies to ensure product safety and efficacy throughout the design transfer and manufacturing processes.
• Change Management: Managing changes in design, processes, and regulations efficiently to minimize disruptions and ensure continuous improvement.
• Validation and Testing: Overseeing validation and qualification activities, including factory and site acceptance testing, test method validation, and ensuring that all processes and products meet predefined criteria.
• Quality Systems: Expert in more than one Quality System Subsystems along with strong understanding of interdependencies and impact of project deliverables and decisions across Quality Subsystems. Demonstrated experience in working effectively to ensure quality and compliance requirements are designed/built into the products Demonstrated understanding of product development lifecycles, design change and change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Strong Project Management Skills: Effective planning, scheduling, and resource allocation are essential to manage the complexities of design transfer & new product introductions.
• Cross-Functional Collaboration: Working closely with R&D, quality assurance, regulatory affairs, and manufacturing teams ensures that all aspects of the product development lifecycle are aligned and any potential issues are addressed early.
• Effective Communication: Clear and consistent communication with all stakeholders, including team members, suppliers, and regulatory bodies, is vital to ensure that everyone is on the same page and any issues are promptly addressed

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Diabetes

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The base pay for this position is $111,300.00 – $222,700.00. In specific locations, the pay range may vary from the range posted.