Sr. Manager, Quality Assurance - Quest Medical, Inc.

Summary:

The Director Quality Assurance leads the Quality Operations and Quality Engineering teams to ensure exceptional product quality and regulatory compliance. This role involves strategic project management to balance multiple projects with competing priorities. Key responsibilities include developing Quality Control Plans, utilizing data to enhance Quality Control and CAPA operations, and validating test methods. The manager reviews and approves critical documents such as Device History Records, SOPs, Validation Protocols, Deviation Reports, and CAPA Reports to ensure operational support and compliance.

Additionally, the Sr. Quality Assurance Manager manages environmental monitoring in production areas, oversees sterilization validation activities, and leads root cause analysis investigations for effective CAPA resolution. The role also involves qualifying and monitoring suppliers, deploying risk mitigations to ensure product safety, and participating in regulatory inspections and customer audits. Continuous innovation and improvement of testing methods and processes are essential aspects of this position.

General Duties and Responsibilities:

• Manages and develops the Quality Operations and Quality Engineering leadership staff.
• Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization
• Develops effective Quality Control Plans to assure world-class product quality.
• Utilizes data as related to the Quality Control and CAPA operations.
• Develops and validates test methods, performs data analysis, and writes/revises SOPs.
• Reviews and approves documents, including Device History Records, Standard Operating Procedures, Validation Protocols and Reports, Deviations, Engineering Change Requests, and Non-Conforming Materials Reports, CAPA Reports, Complaint investigations and Supplier Corrective Action Reports to ensure operational support and compliance.
• Manages the environmental monitoring program in applicable production areas, including sterilization validation and re-validation activities.
• Leads root cause and failure analysis investigations to ensure effective CAPA resolution.
• Continuously innovate and improve methods and processes. Defines optimum approaches in testing and analyzing data for each test being performed.
• Acts as assistant to Management Representative during customer and regulatory audits. Participates in regulatory inspections and customer audits.
• Qualifies new suppliers as needed and perform routine supplier monitoring activities.
• Deploys effective risk mitigations to assure product safety and efficacy.

Qualifications

• Bachelor’s degree in a technical or scientific discipline is required.
• A minimum of ten years of experience in a quality or regulatory position, preferably in the medical device industry. Experience with EO sterilization processes, sterile product assembly and packaging, and electronics assembly preferred.
• A minimum of five years of management experience or 10 years in a quality leadership role.
• Excellent working knowledge of the FDA’s 21 CFR Part 820; ISO 13485; EU Medical Device Directive (93/42/EEC); Canadian Medical Devices Regulation (SOR98-282); Japanese MHLW Ordinance 169; RDC ANVISA 16/2013, Australian TG(MD)R, ISO 14971, ISO 9001, and Medical Device Single Audit Program (MDSAP). Experience with IEC 60601 preferred.
• Experience in supporting FDA inspections as a quality system subject matter expert and an ability to interpret regulatory requirements.
• Detail oriented and possess a professional demeanor, be adaptable to changing environments, handle diverse workloads, and capable of completing tasks with little or no supervision.
• Demonstrated ability to work in a highly cross-functional environment.
• Excellent technical writing experience within a medical device environment is essential.
• Strong root cause analysis skills.
• Ability to use sound scientific judgement and risk management for the facility to prevent regulatory action.
• The ability to work with minimal supervision to prioritize tasks and be able to manage several projects and tasks simultaneously to meet deadlines; and the ability to interface with all levels of management.
• Certified Lead Auditor or ASQ certification as a Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) strongly preferred.