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Abbott Senior Manager Design Quality Assurance in Alameda, California

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, 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.

Our location in Alameda, CA currently has an opportunity for a Senior Manager Design Quality Assurance.

You will manage the site validation and design quality engineering teams to provide a Quality Assurance service to the Alameda site with regards to guidance on validation and design control strategies; guidance on product, process, equipment changes, which may or may not require a design change and/or re-validation. Support the development, manufacture and delivery of quality and compliant products on time, in full and cost effectively to meet the needs of the business and customers; support core values and behaviors as defined by ADC. Work closely with the Technical, Engineering, and Research & Development functions in order to ensure changed or new product/processes are implemented in compliance with ADC, Corporate and cGMP requirements, and in a timely manner to ensure ADC business goals are met. Assure that the site has policies, processes and procedures in place so that site activities, with regards to design control, process validation and on-market change control, meet applicable quality and regulatory standards, divisional and local requirements. Support, lead and sponsor improvement initiatives; identify and implement change, validation and design process quality improvements. Maintain the metrics required to monitor the compliance of the change, validation, and design control processes, escalate issues when necessary Act as a Subject Matter Expert (SME) for application of statistical sampling plans, Design of Experiments (DOE) and design and process failure modes and effects analysis (FMEA). Act as a Subject Matter Expert (SME) for change, validation and design control processes during internal and external Quality System audits.

WHAT YOU’LL DO

  • Managethevalidationand designqualityengineering team to provide strategic direction for QualityAssurance of Medical Devices for Diabetes management.

  • Support thedevelopment,manufacture anddeliveryof quality andcompliant Diabetes management products.

  • ADCs innovative product cross the boundaries between traditional Diabetes management tools to state of the art digital glucose sensing products using mobile apps and other software products.

  • This role works closely with hardware and software development teams to ensure quality compliant products.

  • Works with manufacturing teams to ensure robust validation activities occur in a timely manner.

  • Oversee the review and approval of on market change processes, validation packages and design control related documentation generated on site such that the Quality Records comply with site and regulatory requirements.

  • Establish service level agreements to ensure timely completion and monitor teams performance in support of the sites validation, design control and on market change projects to ensure best speed to market for new/changed products.

  • Participate in the progress of failure/quality investigations and CAPAs associated with site validation and design control activities.

  • Implement and maintain site change, validation and design control activities through management of the Validation & Design Control QA group and interaction with the groups that execute such tasks.

  • Ensure that members of the department stay current on the requirements, practices, and training of the validation and design control regulations and guidance documents.

  • Work with ADC UK, Ireland & US personnel to ensure the development of consistent, best practice validation and design control policies and procedures.

  • Manage the Validation & Design QA budget to ensure spending is within agreed limits.

  • Support the development of cost efficient business processes whilst ensuring compliance and quality requirements are met.

  • Take responsibility for financial planning of Validation & Design QA for future budget cycles.

EDUCATION AND EXPERIENCE YOU’LL BRING

Minimum of a Bachelors degree, or equivalent in a technical discipline. A degree in a technical discipline ensures a basic understanding of the chemistry and principles of the products that are manufactured at the site. Validation and design control system experience (3-5 years) required to lead an effective group. Knowledge required of regulations and standards affecting in-vitro diagnostics (IVD) and medical devices (MD), such as FDA QS Regulations Part 820 & Part 11, ISO13485, ISO14971 and cGMP required for maintaining validation and design control compliance. Quality Management (2 years) required to understand and promote Quality standards. Project Management (2 years) required to manage group activities. People Management (2 years) required to manage Validation and Design QA group. The incumbent needs to have excellent written, negotiation and oral communication skills. The ability to work effectively across a matrixed organizational structure and be a team player is a key requirement. The incumbent needs to be receptive to change and be able to drive change, consistent with drive towards ADC core values. Note: Any formal certification in the area of cGMP, Quality management, and/or design/validation is highly desirable.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • A fast-paced work environment where your contribution is essential to success

  • Training and career development , with onboarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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