Associate Manager, Quality Assurance

1 week agoPotters Bar, United Kingdom

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Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

Provide quality engineering leadership and technical guidance in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.

What you will do:
Working in the Quality Operations structure, in a supervisory capacity, has responsibility for, but not limited to the following:

  • Lead teams to support products in development, production or customer experience including issue investigation, corrective action, preventive action, supplier management (as appropriate), and risk management.
  • Work closely with operations and the business functions to ensure quality performance of product and processes.
  • Collaborate with Divisional QA, cross-functional and supplier teams to address top quality issues.
  • Provide leadership direction to team on problem solving and process improvements, address obstacles, provide resources and interact with other areas of the company to assist the team in overcoming problems and streamlining the work process.
  • Plans, conducts, and supervise assignments.
  • Reviews progress and evaluate results.
  • Support continuous improvement activities.
  • Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
  • Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
  • Recruit, select, and on-board top talent.
  • Develop talent within team to increase performance. Actively address performance issues on team, including supporting with performance appraisals and any Employee Relation issues that may occur, in collaboration with HR
  • Maximise employee engagement as measured by the Company's employee engagement survey, while maintaining a strong focus on individual and team performance
  • Own or support identified internal and supplier non-conformances and manage the timely closure of NC's and CAPA's.
  • Support execution and analysis of manufacturing related complaints and product field actions.
  • Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
  • Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
  • Engage in the development and improvement of internal manufacturing processes for existing products.
  • Performs critical assessment of internal and supplier proposed change management activities.
  • Participates and may lead in the creation and/or review of new or modified procedures.
  • Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
  • Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
  • Support the creation and maintenance of inspection methods and sampling.
  • Engage and interface in internal and external audits providing subject matter expertise
  • Support the development and review of process and equipment validation/qualification and MSA of internal processes.
  • Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.
  • Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
  • Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.
  • Drive continuous improvement actions to reduce manufacturing defects.
  • Provide leadership and subject matter expertise in QA activities to the overall site.
  • Actively promote company culture, mission & values.
  • Any other additional responsibilities required by the company

What you need:
  • BS in a science, engineering, Master's Degree or equivalent preferred.
  • Minimum of 6 years relevant experience; Minimum 1 year supervisory experience preferred.
  • Experience in Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment preferred
  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements. Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
  • Demonstrated ability to collaborate effectively with and lead cross-functional teams.
  • Demonstrated ability to effectively prioritize and manage multiple project workloads.
  • Demonstrated knowledge of adverse event reporting, complaint investigation, CAPA, and corrective action processes.

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Job ID: Stryker_Combined-ejiQudcmy4wZ