Manager Quality Assurance Reliability - Abbott Vascular - Temecula, CA

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 114,000 colleagues serve people in more than 160 countries.

Manager Quality Assurance Reliability

Working at Abbott

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. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Your 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
  
  

The Opportunity

This position works out of our Temecula, CA location in the Vascular Division.

MAIN PURPOSE OF THE ROLE

Incumbent serves as process owner for Complaint Handling Investigation process. They are the subject matter expert and representative for the Formally Designated Unit (FDU) and serve as a contact for the complaint investigation process during audits, inspections and assessments by regulatory agencies, globally. Works closely with manufacturing sites to identify potential product deficiencies and works with team to timely open exceptions for further investigation of these issues. In addition, provides support to the Commercial Teams when inquiries are made about product experiences, including meeting with physicians and hospital staff. Additionally, this position is responsible for personnel development and assessing performance. Provides direct and indirect supervision to professional, direct or indirect labor staff to ensure that complaints are handled in accordance with global regulations and internal procedures. Ensures that compliance is maintained and that employees are trained and following the required divisional and Abbott policies and procedures. Interacts with division's Senior management in the area of complaints handling and issues affecting product performance. Anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate cross-functional areas to recommend actions to resolve issues.

What You’ll Do

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Identifies and recruit’s staffing / resources to support complaint handling activities and on-market support for all Vascular products.
• Identifies and implements the organizational structure necessary to achieve business objectives and QA compliance within the complaint handling organization.
• Ensures complaints are investigated in a meaningful way to identify product deficiencies.
• Champions and actively participates in development / improvements of complaint handling processes and procedures.
• Work effectively with R&D, as well as other internal and external organizations as needed, to coordinate and facilitate improvements in AV products based on feedback received in complaint handling processes.
• Works closely with PPG Data Management, Supplier QA and Operations teams to ensure that exception reports and corrective and preventive actions are conducted as necessary for complaint issues.
• Facilitate meetings and discussions across multiple organizations as required to improve/enhance complaint handling processes.
• Participate in monthly tracking and trending meetings - provide input on early trends that may not yet be reflected in the
• data.
• Responsible for ensuring that product quality issues are identified as early as possible and remedied through the corrective and preventive action system.
• The incumbent also has a high level of interaction with FDA / Notified body during inspections.
  
  

Required

Required Qualifications

• Bachelor's Degree in a scientific or technical discipline
• Minimum 8 years - Quality experience in medical devices or pharmaceutical regulated environment
• Minimum 3 years - Managing/leading organizations
• Minimum 2 years - Complaint Handling Experience
  
  

Preferred

• Master's Degree in a scientific or technical discipline
• Previous medical device experience, including root cause investigation and determination of corrective actions.
• Substantial knowledge of CFR 820, 803, 806, ISO 13485 and ISO 14971
• Must have demonstrated solid knowledge and experience in discipline. Demonstrated leadership competencies.
• Considered a Subject Matter Expert.
• Demonstrated ability to lead cross-functional projects.
• Flexibility, strong problem-solving skills, excellent written and oral communication skills, solid organizational ability, negotiations skills with ability to drive cross functional teams.
• Emerging leader that demonstrates strong leadership competencies
  
  

Misc

• This is an on-site role - not a remote role.
• There is no relocation provided for this role.
• This role is base in Temecula, CA.
  
  

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.

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

The base pay for this position is $127,300.00 – $254,700.00. In specific locations, the pay range may vary from the range posted.