Senior Manager, Quality & QMS Build the quality system for a growing medical device manufacturer Intech is hiring its first senior quality leader to build and own our Quality Management System and take the site through

ISO 9001

certification. This role has real ownership. You'll own the QMS and have independent authority to find quality problems and put corrective action in place. You'll report to the Site Manager and work closely with Operations, Engineering, Supply Chain and Product Development. The goal is quality built into how we make product, not an inspection step at the end. You'll set strategy, and you'll also spend time on the manufacturing floor working with our team to build processes that are practical and last. About Intech Intech, Inc. is a precision manufacturing company in Acton, Massachusetts, with a history going back to 1966. Intech makes the highly engineered precision components used in Acra Cut's neurosurgical devices, including its disposable cranial perforators for craniotomy procedures. In April 2026, NSK America acquired Intech and Acra Cut, and both became part of the global Nakanishi organization. The acquisition brings Intech's specialized U.S. manufacturing capabilities together with NSK's established surgical business and its global resources. Intech is now an important U.S. manufacturing operation within NSK America's growing Surgical Division. What you'll do Own the design, implementation and continuous improvement of the site's QMS Lead the organization through

ISO 9001

readiness and certification Build document and record control, quality policies, procedures and work instructions Own the CAPA and nonconformance processes, and lead root-cause investigations on significant and recurring issues Set inspection, testing, sampling and process-control requirements across production Partner with Operations and Engineering to reduce scrap, rework and defects Build and run the internal audit program, and serve as the primary quality contact for customer and certification audits Build supplier quality processes, including qualification, monitoring and supplier corrective action Set quality metrics, run management review and report quality performance to leadership Coach and train employees at all levels and build a culture of prevention and accountability What you bring Demonstrated experience taking an organization through

ISO 9001

certification (required) 7+ years of progressive experience in quality, quality systems or manufacturing quality A track record of implementing or significantly improving a QMS Hands-on experience with CAPA, nonconformance management, root-cause analysis and corrective action Experience leading internal and external audits Experience working directly in a manufacturing environment Supplier quality experience, including supplier corrective actions Comfort working with production staff and senior leadership alike The ability to build structure where the QMS is still taking shape Bachelor's degree in Quality, Engineering, Manufacturing, Science or a related field, or equivalent experience Preferred Medical device manufacturing experience

ISO 9001

Lead Auditor or Internal Auditor training or certification ASQ certification (CQA, CQE or CMQ/OE) SPC, process capability, risk management or other quality engineering tools Lean Six Sigma or other continuous improvement experience Familiarity with medical device quality and regulatory requirements Compensation $140,000 to $160,000 base salary, plus bonus. Final pay depends on experience and qualifications. Location This role is fully on-site in Acton, MA, about 45 minutes northwest of Boston. We're prioritizing candidates who live within a reasonable commute of the office. Intech is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Pay:

$140,000.00 - $160,000.00 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 Application Question(s): Do you bring a strong working knowledge of

ISO 9001?

Do you bring experience taking an organization through

ISO 9001

certification? Do you bring demonstrated experience implementing, managing, or significantly improving a Quality Management System? Do you bring demonstrated experience with CAPA, nonconformance management, root-cause analysis, and corrective action?

Experience:

quality, quality systems, manufacturing quality, or related : 6 years (Required) Ability to

Commute:

Acton, MA 01720 (Required)

Work Location:

In person