COMPANY OVERVIEW
Boyd Biomedical is a commercialization partner for biomedical innovators. We provide an integrated suite of services to help our clients design, build, and launch biomedical devices. We help translational research institutions, start-up biomedical companies, mid-sized enterprises, and large biomedical companies successfully commercialize biomedical innovations across the life sciences industry. The Company is a Massachusetts corporation headquartered in Lee, Massachusetts, with divisional offices in Boston, Massachusetts and Waltham, Massachusetts.
Job Summary
The Director of Quality leads the Quality Assurance and Quality Engineering functions within Boyd Biomedical. This leadership role is accountable for the strategy, performance, and development of the Quality organization, and owns the company's Quality Management System (QMS), process validation, and compliance across medical device contract manufacturing programs. The Director drives departmental excellence, cross-functional execution, and continual improvement from early-stage program transfer through high-volume commercial production, while ensuring compliance with ISO 13485 and FDA requirements, and works in close partnership with Process Engineering and Technical Services to ensure manufacturing processes remain validated, sustained, and inspection-ready.
This position collaborates closely with Manufacturing, Program Management, Account Services, and Design Services to ensure all processes and products meet customer and regulatory requirements. Serving as Management Representative and a primary quality leader and strategic partner to the CEO, the Director of Quality helps shape Boyd Biomedical’s capabilities, customer experience, and competitive positioning in the biomedical contract manufacturing market.
Core Competencies & Behavioral Anchors
· Strategic leadership and organizational development
· Analysis and reasoning
· Decision making and judgment
· Compliance leadership
· Attention to detail
· Results focused and initiative
· Development and continual learning
· Emotional intelligence
· Technical leadership and mentorship
· Cross-functional collaboration
Essential Duties & Responsibilities
Departmental Leadership & Strategy
- Provide strategic direction and operational leadership for the Quality Assurance and Quality Engineering functions within the Build by Boyd division.
- Establish and monitor departmental goals, KPIs, and performance metrics for the quality assurance and quality engineering functions, aligned with division and company objectives; report on results to senior leadership.
- Build and manage staffing plans, allocate quality assurance and quality engineering capacity across active programs and proposals, and develop a high-performing, scalable team.
- Foster a culture of accountability, technical excellence, continual improvement, safety, and regulatory compliance across the quality organization.
- Establish methods, procedures, and best practices to achieve department and division goals.
- Coordinate workload, project assignments, and prioritization across the quality assurance and quality engineering teams to support on-time customer commitments.
Quality Assurance
- Own and maintain the Quality Management System per ISO 13485 and 21 CFR 820.
- Serve as Management Representative and primary host for customer, regulatory (FDA), and notified body audits and inspections.
- Hold final disposition authority to approve or reject incoming materials, in-process product, and finished device lots prior to release.
- Oversee document control, change control, and record retention.
- Lead the internal audit program.
- Maintain compliance with FDA establishment registration.
- Maintain and continuously improve quality policies, procedures, and the Risk Management and Regulatory Strategic Plan to ensure compliance with ISO 13485 and 21 CFR Part 820.
- Review quality agreements with new customers.
- Advance Boyd Biomedical’s culture of quality across the manufacturing organization, and identify resource needs for quality-related functions.
Quality Engineering
- Chair the Material Review Board (MRB) and hold final, binding disposition authority over nonconforming materials, in-process product, and finished goods.
- Manage the corrective and preventative actions (CAPA) system, perform root cause analysis for internal and supplier non-conformances and customer complaints, and drive corrective actions through to closure.
- Manage the approved supplier list and oversee third-party relationships supporting the ISO Class 7 cleanroom and environmental monitoring program.
- Drive process design, characterization, and validation strategy across manufacturing transfer, product introduction, scale-up, and sustainment phases.
- Oversee development and execution of IQ/OQ/PQ strategies, Validation Master Plans (VMPs), protocols, and reports for new and transferred processes.
- Lead and oversee FMEA development and drive corrective actions to closure.
Cross-Functional Collaboration
- Collaborate with Manufacturing, Account Services, and Design Services to ensure alignment on process, equipment, material, and quality strategies.
- Partner with Process Engineering and Technical Services on manufacturing transfer, equipment selection, process troubleshooting, and sustainment activities, ensuring new and existing programs meet quality and validation requirements.
- Provide quality and validation input into process flow, manufacturing strategy, and design-for-manufacturability (DFM) discussions for new programs and product transfers.
- Support proposal development and customer technical reviews, presenting Boyd Biomedical’s quality and process capabilities and approach with confidence and clarity.
- Lead Management Review Meetings and participate in Sales and Operations and Safety Committee meetings to coordinate activities, enforce safety practices, and identify risks and hazards.
Other Functions and Duties
- Champion quality assurance and quality engineering tools and systems, including Minitab, SolidWorks, SharePoint, MRP/ERP, and document control/training platforms.
- Develop, implement, and monitor key performance indicators (KPIs) for the quality assurance and quality engineering functions.
- Monitor quality performance in areas of rejects, scrap, and rework; highlight problem areas and recommend and implement solutions.
- Complete Certificates of Compliance/Analysis and supporting data analysis for outgoing shipments, as needed.
- Positively represent the organization's culture, values, and reputation at all times — in person and online — with staff, customers, suppliers, partners, and regulatory and official bodies.
- Maintain vendor relationships to support equipment lifecycle management and ongoing service needs.
- Travel as needed.
- Other related duties as directed by management.
EXPERIENCE, EDUCATION, CERTIFICATIONS, OR OTHER REQUIREMENTS
Knowledge, Skills & Abilities
- 10+ years of progressive experience in a cGMP-regulated environment, spanning both Quality Assurance operations (batch/lot release, audit hosting, QMS ownership) and Quality Engineering/Validation, with at least 4 years in a leadership capacity.
- Expert knowledge of quality systems and regulatory requirements applicable to medical device contract manufacturing, including ISO 13485, ISO 9001, and FDA 21 CFR Part 820.
- Advanced understanding of IQ/OQ/PQ processes, process capability, and statistical methods.
- Solid understanding and applied experience with Lean and Six Sigma principles and continuous improvement methodologies.
- Ability to keep accurate, detailed records using good documentation practices, and to create and track quality assurance and quality engineering metrics that demonstrate improvement.
- Experience with MRP/ERP systems and document control/training platforms to manage CAPAs, SCARs, and record and training requirements.
- Ability to translate product requirements into technical specifications and manufacturable processes.
- Proficiency in MS Office, SolidWorks, and Minitab.
- Must be able to complete a post-offer, pre-employment criminal background check and drug screen.
Certification / License
ISO 13485 certification, Six Sigma Green Belt or Black Belt certification, ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or PMP certification preferred. Valid driver's license with a clean record.
Education
Bachelor's degree in an engineering, quality, or related technical field (mechanical, biomedical, manufacturing, chemical, or industrial engineering preferred). Master's degree a plus.
— OR —
Any combination of academic education, professional training, or work experience that demonstrates the ability to perform the duties of the position.
Pay: $110,000.00 - $140,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
