Quality Systems Manager - Audit & Regulatory (Hybrid)

Getinge; Merrimack (NH); Hybrid; USD 115,000 - 140,000; Full time

Benefits offered by this job

Health insurance

401k plan with company match

Paid Time Off

Wellness initiative and resources

Life Insurance

Disability benefits

Flexible Spending Accounts

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge is seeking a Manager, Quality Systems in Merrimack, NH to lead quality initiatives including audits and regulatory readiness. You will serve as Backroom Manager during external audits, manage QS project timelines, and coordinate responses to regulatory requests.

Role requires a strong background in QMS, FDA/ISO standards, and continuous improvement. Collaboration with Quality, Regulatory, Engineering, and Operations is essential, with a hybrid work arrangement and competitive

Qualifications

• Bachelor's degree in engineering or science or equivalent experience.
• Minimum of seven years of experience in medical device, pharmaceutical, or regulated industry.
• Strong knowledge of Quality Management Systems (QMS) and FDA/ISO requirements.

Responsibilities

• Lead Quality Systems initiatives, audits, and regulatory inspections.
• Manage timelines and milestones for QS projects from initiation to closure.
• Coordinate external audits and responses; track observations and commitments.
• Generate status updates and align QS activity with PMO and governance.

Skills

Quality Systems

Audits

Regulatory inspections

Project management

Continuous improvement

Attention to detail

Communication

MS Office

ERP SAP

Education

Bachelor's degree in engineering or science

Tools

SAP

MS Office

Job description

Getinge is seeking a Manager, Quality Systems in Merrimack, NH to lead quality initiatives including audits and regulatory readiness. You will serve as Backroom Manager during external audits, manage QS project timelines, and coordinate responses to regulatory requests.

Role requires a strong background in QMS, FDA/ISO standards, and continuous improvement. Collaboration with Quality, Regulatory, Engineering, and Operations is essential, with a hybrid work arrangement and competitive