In this exciting role as a Senior Design Quality and Compliance Manager, you will have responsibility for leading and managing quality assurance of medical device products and managing the quality management system in the compeny’s Patient Monitoring business.
The Design Quality team you will lead ensures that design control is properly maintained and executed, released products meet performance expectations, and changes to current product designs and service/repair of products in the field follow the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies.
The compliance team you will lead oversees the compliance and customer quality activities such as: preparing and hosting the site management review, running the Corrective Action Board, managing internal and external audits, reviewing and completing activities defined in customer quality agreements, and handling document control. In addition, you will provide leadership, oversight and training to Quality and Engineering on a broad range of topics including change control, risk management, trending & escalation, statistical methods, and CAPA.
A Day in the Life
You will Oversee and manage Quality Engineers who provide quality support to new product development, design changes and sustaining engineering projects.
You will Provide strategy and structure for released product quality support including complaint trending, escalation, CAPA investigation and execution.
You will Establish complaint and reliability predictive metrics to drive improvement in the business. Support Design for Reliability and Manufacturability initiatives.
You will Oversee and manage the Quality System specialists who maintain the quality management system including management review, CAB, internal audit scheduling, quality planning, customer quality, and document control.
You will Support activities such as Issue Impact Assessment, product holds, field corrective actions, and regulatory requests for additional information.
You will Interact with auditing body agencies during audits.
You will Manage department resource allocation across multiple functions.
You will Drive change, demonstrate effective decision making, and provide direction for quality operations.
You will Provide guidance and development opportunities for department employees.
Must Have: Minimum Requirements
BSc in Engineering with strong background in electronics and software.
Quality Auditor experience for ISO13485.
Previous supervisory responsibility 7-10 years in quality engineering with at least 5 years in the medical device industry, or equivalent work experience and/or professional qualifications.
Nice to Have (Preferred Qualifications)
Six Sigma or Lean Certification(s) desired
Quality Certifications: e.g. Certified Quality Engineer/ Manager, Certified Reliability Engineer, Certified Quality Auditor
Excellent communication skills
Ability to work effectively within team and across functions
