Product Quality Analyst IIIThe Opportunity The primary function of a Product Quality Assurance Analyst III is to assist in identifying, reviewing and facilitating assessments of the impact of worldwide product nonconformances on ADC products that arise as the result of complaint investigations, manufacturing deviations, trend analysis or software defect reviews. This may include managing the completion of product containment activities and Risk Evaluations, and associated activities addressing the product nonconformances, and including the escalation of higher risk nonconformances to executive management.
This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.
What You'll Work On- Reviewing escalated customer complaints, exception/ nonconformance reports, manufacturing deviations and regulatory requirements against existing historical analysis to identify new issues and Risk Evaluations as required.
- Facilitate 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 digital product containment activities, and subsequent product dispositions in alignment with the nonconformance/ exception report processes as applicable.
- Assist in completing product accountability for Quality Holds.
- Initiating and facilitating the Risk Evaluation processes, including facilitating cross-functional team recommendations as a result of the Risk Evaluations.
- Drafting, reviewing, and managing the approval of Risk Evaluations with input from cross functional teams.
- Preparing and participating or facilitating in Risk Evaluation Executive Management Review meetings with Senior Level management.
- Escalate grey market, diverted, counterfeit, or stolen product issues to Global Product Protection.
- Draft, review and implement process improvements through procedures and work instructions.
- May assist with drafting and execution of field actions as they arise, along with Advisory Notices, and associated documents.
- Provides direction to junior staff on daily activities.
- Escalate issues to Management and may serve as delegate for management as appropriate in various capacities.
- Collate Risk Evaluation and Product Containment, and associated complaint data, and draft summary slides for Post-Market Surveillance review activities.
- Support audit activities including compiling lists, pulling and reviewing PQA documents, and working on audit responses.
- Review investigation reports related to new, previously unidentified product defects/ deficiencies, that require a Risk Evaluation.
- Reviewing emerging global regulations for the impact on PQA processes.
- May review Risk Evaluations and other PQA documentation from junior team members and provide constructive feedback.
- Lead issue escalation activities including Risk Evaluation Executive Management Reviews.
- Identify the need for, manage, and implement team process improvement projects/ activities.
- Responsible for adhering to quality policies.
- Maintaining original files in PQA archival system.
Required Qualifications- Bachelors Degree with a minimum of 8 yrs of experience or equivalent education and work experience will be accepted.
- Related work experience, especially in product Risk Management for medical devices, customer complaints, and product nonconformances. Prior experience in the medical device industry and/ or quality systems are required.
- Strong working knowledge of FDA Code of Federal Regulations as it applies to medical device manufacturing, including cGMP, ISO14971, as well as complaint handling systems.
- Proven track record of managing projects from initiation to completion in a timely manner.
- Strong technical writing skills and excellent oral and written communication skills
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Divisional InformationMedical 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 $112,000.00 - $224,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:ADC Diabetes Care
LOCATION:United States > Alameda : 2601 Harbor Bay Parkway
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:No
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
