Manager (Principal Quality Engineer), Medical Device Quality Systems
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.
You provide guidance to operational teams for managing projects and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies.
You will be responsible for development, implementation , and management of Kalamazoo site Quality Systems for Medical Device/Combination Products. You will Lead and support the creation, development and monitoring of Quality and Regulatory Compliance strategies for medical devices and combination products. Ensuring inspection readiness and compliance with all applicable medical device and combination product regulations within the scope of the manufacturing site’s activities. You will manage quality systems improvement plans and ensure timely escalation of issues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It
- Responsible for maintenance of Medical Device and Combination Products Quality Management Systems including remediation and continual improvement.
- Development, implementation and monitoring of Quality and Regulatory Compliance strategies for medical devices and combination products.
- Ensures inspection readiness and compliance with all applicable medical device and combination product regulations within the scope of the manufacturing site’s activities.
- Leads the evaluation of adequacy and compliance of the site Quality Management System against all applicable medical device/combination product regulations, company policies, and procedures.
- Manages quality systems improvement plans.
- Develops and delivers training to ensure medical device and combination product quality concepts and processes are understood throughout the site.
- Supports device Management representative in preparation for device Management Review Meetings with timely inputs as required for leadership escalation.
- Provides strategic support for MDCP Internal & External Audits and regulatory inspections.
- Authors, reviews and / or approves GMP related SOPs and documents.
- Monitors ongoing industry quality and regulatory compliance matters applicable to device/combination products and ensures required updates are implemented in a timely manner. Acts decisively, demonstrates sound judgement supported by newly-developed data and where past practices do not apply in dealing with situations of difficult or highly complex nature or impact
- Supports technical execution of Design History File (DHF) enhancements / updates.
- Ensures device risk management files are updated regularly incorporating post-production information.
- Responsible for process compliance and adherence to all CAPA regulation requirements.
- Supports senior level functional members of management assigned to the CAPA Review Board (CRB).
- Develops and monitors key metrics and provides input to device management reviews.
- Monitors and analyzes key performance indicators and ensures identified trends and issues are appropriately escalated and addressed promptly.
- Reviews and approves change requests for potential impact to device design and/or DHF document impact.
- Lead Medical Device regulation Gap Assessment and Correction efforts
- Coaches fellow colleagues, developing their technical expertise, provides guidance to others in decision making
- Participates on common interest groups across the network
- Drives medical device or combination product issue investigations and assigned CAPAs.
- Reviews PQS requirements related to Medical Device and Combination products and assesses impact to Quality Management System.
- Bachelor's degree in Chemistry, Biochemistry, Engineering, Life Science or other technical degree.
- Minimum 5 years experience in Medical Device or Combination Products Quality, Design Controls, Production, or related field.
- Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485:2016 requirements and related standards.
- Understanding Quality Management Systems in a GMP regulated environment.
- Proven written and oral communication skills based on good Pfizer leader behaviors.
- Experience developing, managing, and designing compliant device Quality systems as evidenced by positive device inspectional outcomes.
- Medical device QMS architecture expertise.
- Experience remediating and implementing Device Quality Management Systems.
- Demonstrated proficiency in organizational and project management skills.
- Must be able to balance multiple priorities.
- Minimum 7 years of experience in a Medical Device Regulated Environment.
- Minimum 5 years of experience in a Quality Engineering, Quality Assurance role.
- Expertise in FDA regulations and ISO Quality requirements.
- Certification as Quality Engineer granted through American Society of Quality (ASQ).
- Experience facilitating and coordinating compliant device site governance processes.
- 5 years of successful and demonstrated device quality management system remediation to US regulations.
- Office position with time in the production environment.
- First shift position.
- Must be able to work independently, with minimal guidance, and consistently produce quality work.
- Must be able to work in a team environment within own team and interdepartmental teams.
- Must have effective written and oral communication skills.
- Must be able to multi-task, meet deadlines, and maintain a high standard of work even with short timelines.
- Must have the ability to handle complex and detailed situations.
- Eligible for Relocation Package