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Quality Systems Manager

Jobot

Parsippany, NJ

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JOB DETAILS
SALARY
$130,000–$160,000 Per Year
SKILLS
Audit Metrics, Code of Federal Regulations, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Document Control, Employee Assistance Plan, External Audit, FDA (Food and Drug Administration), Flexible Spending Accounts, Healthcare Quality, Hospital, ISO (International Organization for Standardization), Incentive Programs, Insurance, Internal Audit, Leadership, Legal, Life Insurance, Manufacturing, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Equipment, Process Improvement, Process Management, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Risk Management, Surveillance, Systems Administration/Management, Team Lead/Manager, Training/Teaching, Vendor/Supplier Quality Management
LOCATION
Parsippany, NJ
POSTED
1 day ago
Quality Manager Needed For Leading Medical Device Company

This Jobot Job is hosted by: Kevin Finlay
Are you a fit? Easy Apply now by clicking the "Quick Apply" button and sending us your resume.
Salary: $130,000 - $160,000 per year

A bit about us:

My client is a leading Medical Device Manufacturer and are growing! They are looking to add a Quality Systems Manager who will be responsible to lead, maintain, and continuously improve our Quality Management System (QMS) in alignment with ISO 13485, 21 CFR Part 820, and global medical device regulatory expectations. This role is ideal for a hands-on, detail-driven quality leader who has successfully implemented ISO 13485 certification and managed FDA Establishment Registration and device listing activities for manufacturing sites.

Why join us?

Compensation Up To $160,000

Other Benefits Include

Medical, Dental and Vision
401 (k) with company match
Holiday, Vacation and Sick Time
Tuition Reimbursement
Health Savings Accounts (HAS)
Flexible Spending Accounts (FSA)
Cigna Wellness Incentive Program
Employee Assistance Program (EAP)
Short Term Disability
Group Life and Accidental Insurance
Sun Life – Accident, Critical Illness, and Hospital Indemnity Insurance
Smoking Cessation Program
Pet Insurance

Job Details

Responsibilities:

Lead, maintain, and enhance the company’s ISO 13485–compliant Quality Management System, ensuring alignment with FDA QSR and applicable global regulations.
Drive and manage ISO 13485 certification, surveillance audits, and recertification cycles.
Oversee and execute FDA Site Registration, and ongoing regulatory maintenance for the manufacturing site.
Serve as the primary point of contact for regulatory bodies, notified bodies, and customer quality audits.
Manage core QMS processes including: document control, CAPA, nonconformance management, supplier quality, internal audits, training systems, and risk management (ISO 14971).
Lead cross-functional teams to investigate quality issues, implement corrective actions, and drive continuous improvement.
Ensure manufacturing processes remain validated, controlled, and compliant with regulatory expectations.
Develop and deliver quality training across the organization to strengthen quality culture and compliance awareness.
Prepare and present quality metrics, audit findings, and compliance status to senior leadership

Requirements:

Bachelor’s degree in Engineering, Quality, or related field.
10+ years of experience in medical device manufacturing quality systems, with direct ownership of QMS processes.
Demonstrated experience implementing ISO 13485 and successfully achieving certification.
Hands-on experience completing FDA Establishment Registration
Strong working knowledge of 21 CFR Part 820, ISO 13485, and applicable regulatory guidance.
Proven success leading internal and external audits.

Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.

Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.

Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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About the Company

J

Jobot

Jobot is on a mission to connect good people with good jobs. By combining AI-powered technology with the expertise of Jobot Pros, our experienced recruiters, we help you find career opportunities that align with your goals and values.

Founded in 2018 and employee-owned since 2024, Jobot is committed to fostering a culture of kindness, respect, innovation, and connection.  As an industry leader, we’ve been recognized as a top workplace by Forbes, Fortune, USA Today, and Staffing Industry Analysts (SIA).

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COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2018
WEBSITE
http://www.jobot.com