Quality Manager

Technical Needs; Chelmsford (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Technical Needs in Chelmsford, MA seeks a Quality Manager to lead the QA/QC teams in a fast-paced manufacturing setting compliant with ISO 13485:2016.

You will develop and maintain the Quality Management System, ensure regulatory compliance, and drive continuous improvement across functions. This role requires strong leadership and deep knowledge of ISO 9001/13485, AS9100, IPC-A-610, and J-STD-001, plus audits and CAPA management.

Qualifications

• Bachelor's Degree in engineering or related field.
• 5+ years of leadership in QA/Manufacturing or related discipline.
• Experience with ISO 13485/9001, AS9100, IPC-A-610, J-STD-001

Responsibilities

• Lead QA/QC teams to ensure product quality.
• Develop and maintain the QMS to meet ISO/regulatory standards.
• Direct external audits and drive CAPA and change control.
• Foster cross-department collaboration for process improvements.

Skills

Quality leadership

Regulatory compliance

CAPA management

Audits

Change control

QMS development

Cross-functional collaboration

Data analysis

Communication

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Office Suite

Quality management software

Job description

Our client is looking for a Quality Manager to lead and oversee the quality assurance and quality control teams within a high-paced manufacturing environment that adheres to strict ISO 13485:2016 standards. As a Quality Manager, you will be responsible for developing and maintaining the company's Quality Management System, ensuring compliance with relevant industry and regulatory standards, and driving continuous improvement initiatives. In this role, you will manage external audits, lead change control processes, implement corrective and preventive actions (CAPA), and foster cross-departmental collaboration to uphold superior quality standards. This position is ideal for someone with a strong background in quality management systems, regulatory compliance, and team leadership, looking to make a significant impact in a high-growth organization.Work Schedule: Monday-Thursday, 6:00 AM - 4:30 PMRequired Skills, Education and Experience:Bachelor's Degree in engineering or a related technical/science discipline or equivalent work experience5+ years of leadership experience in Quality Assurance, Manufacturing, or a related disciplineWorking knowledge of regulated quality standards such as ISO 9001/13485, AS9100, IPC-A-610, and J-STD-001Excellent verbal and written communication skillsStrong analytical and problem-solving abilitiesAbility to manage multiple priorities and meet deadlines in a fast-paced environmentProficient with Microsoft Office Suite and related softwareThink you know someone who'd be perfect for this role? If you refer someone who gets hired for any of our job opportunities, and works a minimum of hours, we'll show our appreciation with a referral bonus. Spread the word and help us find top talent! Refer someone today: http://techneeds.com/current-employees/referrals/Stay in the Loop: Sign up for email notifications to hear about new openings as they're posted: http://www.techneeds.com/job-seekers/job-alerts/Visit http://jobs.techneeds.com regularly to see our latest opportunities.Techneeds has offered contract-to-hire and direct-hire talent solutions to some of the best employers in New England for over 50 years. As a Technology, Manufacturing, Engineering, Finance, and Professional staffing & recruitment agency, we're experts at finding, screening, and placing in-demand talent with top employers in New England.IND1