Product Quality Analyst Ii

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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
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
This position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.
The primary function of a Product Quality Assurance Analyst II is to serve as a facilitator to identify, review and assess the impact of worldwide product nonconformances or potential nonconformances related to products sold by ADC, and progress product containment, risk evaluation, and field action activities as required.
What you'll work on

• Reviewing customer complaints, exception reports/ quality records, investigation (technical) reports, manufacturing deviations and regulatory requirements against existing historical analysis to identify new issues.
• Participate in cross functional meetings to make recommendations on the need for product control and/ or risk evaluations.
• Drafting, reviewing, and issuing Stop Shipments, Quality Holds, and dispositions in alignment with the exception report/ quality record processes as applicable.
• Initiating and facilitating the Risk Evaluation process, drafting Risk Evaluations and working with cross-functional teams for completion and review.
• Coordinate and execute Field Actions as they arise, from facilitating meetings, to drafting Field Action documents.
• Compiling management review and post-market surveillance metrics and slides.
• Participate in design reviews as required providing technical inputs and historical information for product controls.
• Draft, review and implement process improvements through procedures and work instructions.
• Working across the organization with multiple levels of management to ensure field actions are executed in a timely manner.
• Provides direction to junior staff on daily activities.
• Provides recommendations for product control, risk assessments and field actions.
• Escalate issues to management and serve as delegate for management as appropriate in meetings and audit settings.
• Communicate directly to Customer Service, Sales and Marketing, and other affected areas of the business for new issues as well as product releases via the advisory notice process.
• Responsible for adhering to quality policies.
• Maintaining original files in PQA archival system.
• Makes recommendations and suggestions for decisions to cross functional teams and management as appropriate.
• Communicates directly with senior management when appropriate.
• Leads others in the completion of project tasks.
• Provides guidance and daily supervision for junior staff, and helps to facilitate the removal of barriers impeding the progress of projects.

Required Qualifications

• A bachelor's degree (in a science field, preferred), with a minimum of four (4) years experience preferably in a pharmaceutical or medical device field, or seven (7) years of related experience in lieu of a bachelor's degree.
• Strong working knowledge of FDA Code of Federal Regulations and worldwide regulations as they apply to medical device manufacturing, including cGMP, ISO14971 , as well as complaint handling systems.
• Prior experience in the medical device industry and or quality systems are required.

Preferred Qualifications

• Proven track record of managing projects from initiation to completion in a timely manner.
• Strong technical writing skills and excellent oral, written, project management and communication skills.
• Field Action, Risk Management, and experience with Software defects/ bugs, are all a plus.

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

• 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
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, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$92,800.00 - $185,600.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf