Director, Quality and Regulatory Compliance

Agile Search is seeking a Director of Quality Assurance and Regulatory Compliance to lead a new chapter of growth for a growing, PE backed corporation with a suite of precision medical optics products.

Serves as Management Representative and responsible for all quality assurance and regulatory functions across the company's portfolio and multiple sites, the incumbent will ensure the QMS and all aspects of quality assurance are compliant with current and future US FDA, ISO, and other applicable regulations.

Principal Responsibilities:

Develops and implements quality and regulatory strategies, policies, programs, and procedures, including internal & external audits, inspections, process verification & validation, supplier performance management, customer complaint management, organizational training needs, and corrective and preventive actions (CAPA).

Ensures the company's products meet applicable regulatory requirements and quality standards.

Ensures the company's QMS and all aspects of quality assurance are compliant with current and future US FDA, ISO, ITAR, and other applicable regulations.

Serves as the Management Representative and works closely with cross-functional leaders to manage, develop, and implement Quality initiatives across the organization.

Ensures alignment of quality objectives, individual and departmental goals with corporate strategic

objectives; develops, monitors and reports on quality KPIs and metrics.

Drives the development and implementation of strategic plans and initiatives to deploy/transform and continuously improve QMS tools, software, and processes to help ensure conformance to established quality and delivery targets.

Provides QA/RA department leadership and support to all phases of product development & NPI/transfer programs to help meet DFMA, DFT, and DTC goals.

Develops internal controls, tools, and processes to assure compliance and serves as the

primary internal subject matter expert, overseeing export compliance activities and responding to

BIS inquiries or audits.

Fosters a collaborative and high-performance culture based on Lean and continuous improvement

principles; utilizes best practices, technological advancements, and industry benchmarks to enhance quality and productivity.

Interfaces with key customers during negotiations relating to quality plans, agreements, and regulatory requirements.

Provides leadership to the QA/RA team; mentors, retains, and develops departmental talent.

Education, Training, Skills, Knowledge and/or Experience:

Bachelor’s degree in engineering, or a related technical/science field. Masters degree preferred.

10 years of leadership experience across quality assurance & regulatory compliance in process-oriented medical device manufacturing operations.

Minimum 3 years of experience leading quality management within a significant segment of a large manufacturer or the entire operation of a smaller manufacturer.

Demonstrated experience in implementation and continuous improvement of the QMS and risk management tools to improve quality, reduce costs and improve efficiency.

Direct experience with FDA and/or notified body inspections at a medical device manufacturer.

Excellent leadership and people skills, with the ability to identify/develop talent, and inspire others to achieve.

Change management and process improvement skills to simplify quality/business processes, tools, and workflows.

Demonstrated organizational and leaderships skills, including establishing, supporting, and sustaining a culture of quality and compliance within an organization.

Experience with international registration regulations is a plus.

Lean and/or Six Sigma certification/experience is a plus.

This is an onsite role near Littleton, MA. 20-25% Domestic travel is required.