Senior Manager, Quality Assurance

KARL STORZ

Senior Manager in Quality Assurance leading teams in medical devices at KARL STORZ. Ensuring compliance with FDA, ISO, and global standards while driving quality improvement initiatives.

Posted 4/25/2026full-timeAuburn • Massachusetts • 🇺🇸 United StatesSenior💰 $133,700 - $180,900 per yearWebsite

About the role

Key responsibilities & impact

Lead Quality Assurance, Quality Engineering, and Quality Support teams
Own site QMS compliance to FDA, ISO, MDR, CE, and global regulatory standards
Oversee CAPA, complaints, audits, management review, and quality metrics
Serve as Site Management Representative for audits and inspections
Drive continuous improvement through data analytics and quality best practices
Develop talent, training programs, and a strong quality culture

Requirements

What you’ll need

10+ years of quality experience in medical devices
7+ years of quality auditing experience
3+ years of people leadership experience
Bachelor’s degree; Lead Auditor certification (ISO 9001 or 13485)
Deep knowledge of FDA 21 CFR 820, ISO 13485, MDR, and risk management
Strong communication, analytics, and stakeholder‑management skills.

Benefits

Comp & perks

Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!
3 weeks vacation, 11 holidays plus paid sick time
Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
Section 125 Flexible Spending Accounts
Life, STD, LTD & LTC Insurance
We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
Fitness reimbursement of up to $200 annually
And much more!

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality assurancequality engineeringquality supportdata analyticsCAPAauditingrisk managementquality metricscompliance

Soft Skills

leadershipcommunicationanalyticsstakeholder managementtraining development

Certifications

Lead Auditor certificationBachelor's degree