Job Information
Abbott Manufacturing Line Quality Engineer Supervisor in Westbrook, Maine
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.
Job Title
Manufacturing Line Quality Engineer Supervisor
Working at Abbott
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
The position of Manufacturing Line Quality Engineer Supervisor is within our Infectious Disease business unit located at Westbrook, Maine. In this role you will be responsible for leading a team of Quality professionals ensuring that all communications, interpersonal interactions and business behaviors are consistent with ADC values and the Abbott Code of Conduct. To identify and support staff training and development needs.
Quality Assurance Expertise: Provide Quality Assurance expertise and guidance to ensure new product introductions and design changes meet customer, business, and regulatory requirements.
Quality System Procedures: Develop and maintain ADC Quality System procedures to ensure effective methodologies for Design Control, Process Validation, and Operations QA.
Cross-Functional Relationships: Build and maintain successful relationships with departments such as R&D, Technical, Engineering, Operations, and Regulatory Affairs to achieve project goals.
Health and Safety: Proactively address Health and Safety concerns to reduce hazards and risks. Support the creation and development of an environment where Health and Safety is a shared responsibility, ensuring EHS responsibilities are met.
What You’ll Work On
Resource Coordination: Prioritize and coordinate resources within the QAC group to meet overall demands and achieve project success. Plan individual workloads weekly and provide regular updates on project resource requirements. Resolve conflicts through forward planning and ensure other quality functions are integrated into project teams at appropriate points.
Quality Assurance Representation: Serve as the primary representative for quality assurance functions on assigned project teams. Collaborate with project leads to develop effective, time-saving strategies that meet business goals. Maintain a balance of quality, compliance, and business risk, ensuring teams use appropriate risk management tools to prioritize activities and justify effort levels.
Quality Issue Resolution: Take decisive action to resolve quality issues by providing compliant yet practical solutions that minimize impact on project timelines. Update management on quality and technical issues and resolve disagreements before escalating to senior management.
Quality Records Management: Monitor and maintain the quality and compliance status of associated quality records. Ensure project teams maintain records in compliance with QS and planned requirements. Review, provide feedback, and approve Quality Records, promoting a “right first time” approach and ensuring accountability.
Validation Status Maintenance: Monitor and maintain the validation status of site products, processes, and systems. Maintain process FMEA and equipment software risk analysis records, site validation plans, listings, and periodic reviews. Provide validation input to post-market surveillance activities and present status, metrics, trends, potential issues, improvement initiatives, and CAPA requirements.
Design Control Monitoring: Monitor and maintain the design control status of site products, processes, and systems. Maintain risk management plans and associated records (e.g., design risk analysis and design FMEA). Provide design input to post-market surveillance activities and present status, metrics, trends, potential issues, improvement initiatives, and CAPA requirements. Manage DHF creation and maintenance, change control of product and material requirements, and product performance monitoring of stability and clinical data.
Procedure and Training Maintenance: Maintain the quality and compliance status of associated procedures, work instructions, and training materials. Author, change, and update ADC procedures. Identify and implement continuous improvement initiatives for the Quality System. Provide direction and training based on a thorough understanding of ADC procedures and the quality/regulatory requirements they support. Ensure consistent application of quality and compliance approaches within the business and across the division.
Team Effectiveness: Implement a work environment that ensures team effectiveness. Coach and mentor staff on performance, training, and development needs. Ensure effective communication with other staff and Quality Management to share information and support the attainment of ADC UK Quality goals and business objectives. Provide role model leadership for the group and conduct performance appraisals and development processes. Liaise with QA Management on staff recruitment to maintain appropriate staffing levels.
Additional Responsibilities: Accept any responsibilities and perform necessary tasks to support the business and other QAC activities. Provide support to wider QAC activities based on product and process knowledge gained through evaluation, understanding of end-user needs, design control outputs, on-market surveillance activities, and CAPA investigations.
Required Qualifications
Bachelor’s Degree in a related field or an equivalent combination of education and work experience.
Prior experience of the development and/or manufacture of regulated products to ensure familiarity with cGMP and/or ISO Quality System requirements.
Prior experience of working with 21 CFR 820 and Part 11; and ISO 13485 is required as they relate to Design Controls and/ or Process Validation.
Prior people management experience – required to lead and manage the QA group.
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.
The base pay for this position is $83,000.00 – $166,000.00. In specific locations, the pay range may vary from the range posted.
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