Senior Quality Manager - Medical Devices (6-Month Contract)

Cirtec Services GmbH; Santa Clara (CA); On-site; USD 90,000 - 109,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) retirement plan

Paid time off

Job summary

Cirtec Medical Corporation seeks a Quality Manager to lead Quality personnel and resources, ensuring QMS compliance and coordinating quality engineering activities to support manufacturing and development programs. This role oversees QA, QC, CAPA, audits, and regulatory compliance across Class II and III medical devices.

We require a STEM bachelor’s, 7+ years in a regulated medical device environment, and certifications such as ASQ Lead Auditor.

Qualifications

• Bachelor in STEM related field required.
• Advanced degree preferred.
• Quality and/or Regulatory certification(s) (ASQ, Lead Auditor, etc.).
• Experience with ISO 13485 and 21 CFR 820 (FDA cGMP/QSR) and EU MDR.
• Experience with Class II and Class III medical device development and manufacturing.
• Experience in audits by customers and regulatory agencies.
• Ability to implement quality programs and present data to management.
• Strong communication and leadership skills.
• Hands-on self-starter capable of independent work and teamwork.
• Training or equivalent experience with Microsoft Word, Excel, Power Point and Access.
• Experience coaching and developing direct reports.

Responsibilities

• Oversee Quality Management System compliance and site registration activities.
• Lead Quality Engineering for Design & Development and Sustaining Manufacturing.
• Manage Quality Control for inspection and product release across programs.
• Drive CAPA, risk management, FMEAs and validation activities.
• Provide leadership, mentorship and coaching to Quality staff.
• Support internal and external audits and regulatory certifications.
• Collaborate with cross-functional teams on process improvements.
• Maintain documentation control and records retention across sites.
• Represent Quality in program reviews and quality initiatives.
• Support supplier auditing and management activities.

Skills

Quality leadership

Regulatory compliance

cGMP

Audits

CAPA

Risk management

FMEA

Process validation

Documentation control

Mentoring

Education

Bachelor in STEM

Advanced degree preferred

ASQ Lead Auditor

Tools

MS Word

MS Excel

PowerPoint

MS Access

Job description

Cirtec Medical Corporation seeks a Quality Manager to lead Quality personnel and resources, ensuring QMS compliance and coordinating quality engineering activities to support manufacturing and development programs. This role oversees QA, QC, CAPA, audits, and regulatory compliance across Class II and III medical devices.

We require a STEM bachelor’s, 7+ years in a regulated medical device environment, and certifications such as ASQ Lead Auditor.