The Senior Quality Engineer is responsible, under Director level supervision, for leading, supporting and ensuring continued suitability of the Quality Management System (QMS) with a primary focus on design control, validation, risk management, supplier management, process control, post-market surveillance, complaint handling, CAPA, auditing, change control, document control and training.
Essential Duties and Responsibilities
- Ensure that the Quality System is compliant with domestic and international quality system regulations (21 CFR 820; ISO 13485).
- Promote awareness of the Quality System and provide training to individuals across the organization on quality management principles, tools, techniques and best practices.
- Support the implementation of corporate policies and procedures relating to quality, design control, risk management, project management, process development, supplier management and FDA/ISO compliance.
- Engineer solutions to address product and process quality issues. Work as part of a team to drive forward continual improvement initiatives and address compliance challenges.
- Support the research, development and manufacturing of in-vitro diagnostic (IVD) medical device products. Lead the planning, design, preparation, execution, reporting, and analysis of design verification and validation efforts to qualify materials, tools, equipment, systems, processes, and software used in the testing, processing, manufacturing, storing, and distribution of IVD products.
- Initiate and coordinate the inspection and testing of raw materials, work-in-process, finished goods and environmental conditions.
- Design and develop forms, instructions and sampling procedures for recording, evaluating, and reporting quality and reliability data.
- Manage and maintain design history files, risk management files and device history records to ensure design and development activities are executed as required.
- Coordinate and support the Corrective / Preventive Action (CAPA), Change Control and NCM/MRB systems.
- Support the document control and training system.
- Lead the investigation, reporting, and resolution of customer complaints.
- Conduct supplier audits and partner with suppliers to address Requests for Supplier Corrective Action (RSCA).
- Coordinate and support the annual audit program; manage, schedule, perform and report on internal, external and supplier audit activity.
- Compile and report quality metrics. Assess and report post-market surveillance data in accordance with regulatory requirements.
- Bachelor’s Degree in Engineering, Biology, Chemistry or Life Sciences required, Master’s Degree preferred.
- At least 6 years of experience in a quality role supporting clinical research, pharmaceutical development or IVD development.
- Note: An advanced degree in Biology, Chemistry or Life Sciences accepted in lieu of professional experience.
- ASQ Certified Quality Engineer and Six Sigma Black Belt preferred.
- Thorough understanding of quality philosophies, principles, systems, methods, tools and standards.
- Through understanding of customer expectations, supplier relations and continual improvement practices.
- Experienced in acquiring and analyzing process data using appropriate quantitative and statistical methods across a spectrum of business environments to facilitate process improvement.
- Excellent communication skills
- Excellent writing skills
- Strong organizational skills
- Ability to handle multiple projects simultaneously
- Exhibits self-reliance in managing personal workload and schedule of deliverables
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