Director of Quality Engineering – Medical

Our client is seeking a Director of Quality Engineering with medical device experience for their facility northwest of Boston.  Ideally, the Director of Quality Engineering will be an experienced expert in operating facilities that are ISO certified. The Director of Quality Engineering will lead the quality team in developing and executing Quality operations in-line with our client’s mission and vision. The Director will implement and monitor all company quality systems to demonstrate compliance with all regulatory requirements, including ISO 13485. This position is responsible for providing quality guidance for design, development, and manufacturing strategies related to the production of parts for multiple industries, including medical.

The Director of Quality Engineering must have knowledge of quality systems and compliance to support systems, software, and service. This position is accountable for ensuring all supplier management, manufacturing, new product development, quality control testing, and shipping activities are conducted according to prescribed procedures, policies, and regulations and for leading, managing, and coaching the Quality team. The successful candidate will be a hands-on self-starter with the ability to collaborate and work closely with various teams and functions, including manufacturing, supply chain, finance, facilities, process development, and regulatory procedures to ensure quality GMP standards, compliance with global regulations, and support of regulatory filings and audits.

Director of Quality Engineering Responsibilities will include:

• Evaluate production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
• Assure that all facilities are compliant with ISO 9001 and ISO 13485.
• Manage compliance with the IQ, OQ, PQ process and ensure quality information is recorded correctly.
• Develop an internal audit program that meets every section of the ISO requirements in all facilities.
• Manage the specifications and forms on the company intranet site.
• Assure all quality inspectors are professionally trained and evaluated.
• Assure that the stamp compliance program is compliant and controlled.
• Collaborate with management and senior staff across production departments and roles to draft acceptable quality standards.
• Implement an Operator Quality Certification program.
• Develop and implement quality standard testing and evaluation processes.
• Facilitate communication among production divisions and management.
• Assess test results and approve recommended changes.
• Review quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance.
• Conduct random inspections and quality control checks.
• Periodically report the status of quality control and operations to executive leadership and, when required, regulatory agencies.
• Assure that KPIs are in place, measured, and successful.
• Update and create additional reports and post the results in both facilities.
• Issue Corrective Action Requests and ensure root cause analysis is complete and in place for all quality and operational deficiencies.

Director of Quality Engineering Background profile:

• Bachelor’s degree in engineering or related industrial, scientific, or business field required; Master’s degree preferred
• Eight to 10 years of related experience required, with at least five years as a Quality Manager or similar role highly preferred
• Experienced in production and qualification of medical products and possess an expert knowledge of medical quality systems, audits and FDA regulations
• Oversee and manage a robust internal and supplier audit system
• Expert knowledge of ISO and AS certification standards
• Thorough understanding of quality control standards and methodologies
• Thorough understanding of manufacturing and production standards across multiple industries and knowledge of the IQ, OQ, PQ process
• Knowledge of gage calibration systems and sampling procedures
• Ability to interpret engineering drawings and determine inspection methods
• Excellent team leadership skills and strong supervisory with the ability to hold people accountable to goals and motivate reports

Tagged as: audit, FDA, GMP, IQ, ISO 13485, manufacturing, OQ, PQ, regulatory, supplier