Abbott Product Quality Assurance - Complaint Analyst in Alameda, California
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Primary Job Function
The primary function of a Product Quality Assurance Analyst I is to assist in facilitating the PQA department to identify, review and assess the impact of worldwide product manufacturing, quality, regulatory or safety issues that arise in complaint investigations, manufacturing deviations, trend analysis or other non-conformities related to products sold by ADC.
This includes but is not limited to: Reviewing customer complaints, exception reports, manufacturing deviations and regulatory requirements against existing historical analysis to assist in identifying new issues. Initiating and facilitating the product control processes: Drafting, reviewing, and issuing stop shipments, quality holds and stop build orders and dispositions in alignment with the exception report processes as applicable Initiating and facilitating the risk evaluation processes. Drafting, reviewing, and closing risk evaluations with inputs from cross functional teams. Assist in the coordination of presentations for Senior level management and following up on action items as assigned. Provide data analysis and assist in the PQA department participation in the design review process as required providing technical inputs and historical information for product controls as needed. Participate as a member of Field Action core teams as they arise, drafting documents and facilitating tasks as assigned. Provides guidance to contractor and junior staff during training and as appropriate. Provides data to assist in generation of recommendations for product control, risk assessments and field actions. Escalate issues to management as appropriate. Identify, write exception reports into the GQMS system as appropriate in a timely manner. Responsible for adhering to quality policies. Maintaining original files in PQA archival system Provide inputs in drafting of process improvements.
A bachelor’s degree with a minimum of four (4) years of experience or a minimum of five (5) years of relevant experience in a medical device or pharmaceutical field in lieu of a bachelor’s degree is acceptable.
Minimum Training and Experience
Working knowledge of regulations and standards that apply to medical device manufacturing, such as FDA QSR/ISO 13485 and ISO 14971, as well as complaint handling systems. Prior experience in the medical device industry and or quality systems are required. Proven track record of following through and completing projects in a timely manner. Technical writing skills and excellent oral and written communication skills.
Preferred Training and Experience
Knowledge of FDA – 21 CFR and other regulatory requirements e.g. 21 CFR Part 803, 21 CFR Part 806, IVDD, MDD, MEDDEV 2.12-1, TGA, MHLW, Health Canada, Medical Device Regulations, SOR/98/282 and MHRA.
Quality risk management and regulatory experience in a manufacturing environment
JOB FAMILY: Quality Assurance-Product Improvement
DIVISION: ADC Diabetes Care
LOCATION: United States - California - Alameda
WORK SHIFT: Standard
MEDICAL SURVEILLANCE: Yes
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
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.