Manufacturing Line Quality Engineer Supervisor (2nd shift 2:00 pm-10:30 pm Monday-Friday) at Abbott Laboratories

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.

The Manufacturing Line Quality Engineer Supervisor is accountable for providing Quality Assurance expertise and guidance to ensure that new product introductions and design changes to products and processes meet customer, business and regulatory requirements. Responsible for the development and maintenance of Quality System procedures to provide an effective methodology for Design Control, Process Validation and Operations QA.

The Manufacturing Line Quality Engineer Supervisor is required to build and maintain successful cross functional relationships with departments such as R&D, Technical, Engineering, Operations and Regulatory Affairs in order to achieve all project goals. Required to proactively address Health and Safety concerns within the working environment in order to reduce hazards and risk. To support the creation and development of an environment in which Health and Safety is an individual and collective responsibility and that EHS responsibilities are met.

RESPONSIBILITIES:

• Prioritize and co-ordinate resources within the QAC group in order to meet overall group demands and achieve project success:
• Plan individual workload on a weekly basis.
• Provide regular updates to peers and colleagues on project resource requirements.
• Through forward planning ensure conflicts are resolved.
• Ensure other quality functions are brought into project teams at appropriate points.
• Serve as the primary representative for quality assurance functions on each project team assigned:
• Work with project leads to develop effective and time saving strategies that meet business goals.
• Responsible for maintaining an appropriate balance of quality, compliance and business risk.
• Responsible for ensuring teams use appropriate risk management tools to prioritize certain activities and justify the level of effort required.
• Take decisive action to resolve quality issues:
• Provide compliant yet practical solutions that minimize the impact of Quality issues on project timelines.
• Update management on Quality and Technical issues.
• Take action to resolve disagreement prior to escalating for Senior management involvement.
• Monitor and maintain the quality and compliance status of associated quality records:
• Ensure project teams maintain project records in compliance with QS and planned requirements.
• Review, provide feedback and complete final approval of Quality Records.
• Rigorously promote a “right first time” approach to Quality Records by not tolerating repeated mistakes and ensuring accountability for functional responsibilities.
• Monitor and maintain the validation status of site products, processes and systems:
• Monitor and maintain process FMEA and equipment software risk analysis records.
• Maintain site validation plans, listings and periodic review process.
• Provide validation input to post market surveillance activities.
• Present and communicate status, report metrics, identify trends potential issues, improvement initiatives and CAPA requirements.
• DMR change control.
• IATF/ Online defect handling.
• Product performance monitoring of PT release data.
• Monitor and maintain the design control status of site products, processes and systems:
• Monitor and maintain Risk management plans and associated records e.g. design risk analysis and design FMEA.
• Provide design input to post market surveillance activities.
• Present and communicate status, report metrics, identify trends potential issues, improvement initiatives and CAPA requirements.
• DHF creation and maintenance.
• Change control of product and material requirements (SJP and MSJP change control).
• Product performance monitoring of stability and clinical data.
• Maintain the quality and compliance status of associated procedures, work instructions and training materials:  Author, change and update ADC procedures.
• Identify and implement initiatives for continuous improvement of the Quality System.
• Provide direction and training based on a complete understanding of the intent of ADC procedures and the quality/ regulatory requirements they support.
• Responsible for ensuring approaches to Quality and Compliance are consistently applied within the business and across the Division.
• Implement a work environment that ensures team effectiveness:
• Coach and mentor staff members 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.
• Conduct, plan, and seek input and feedback from multiple sources, for the effective application of the Staff Performance Appraisal and Development process.
• Liaise with the QA Management concerning the recruitment of staff, making sure staffing levels are maintained and recruitment activity is scheduled in line with departmental needs.
• When requested, accept any responsibilities and perform any necessary tasks to support the business and other QAC activities.
• Provide support to wider QAC activities based on product and process knowledge achieved through evaluation/ understanding of end user needs, design control outputs, on-market surveillance activities and CAPA investigations.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required:

• Bachelor’s Degree or equivalent, as the jobholder will need to evaluate technical documentation generated by the Engineers, Scientists and other technical disciplines.
• Prior experience of the development and/or manufacture of regulated products to ensure familiarity with cGMP and/or ISO Quality System requirements.
• Prior people management experience – required to lead and manage the QA group.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

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.