Zollmedicalcorp

Quality Assurance Compliance Specialist I

Chelmsford, MA · Internship

Sponsorship not specified$60k-$70kDetected 8 hours ago
ComplianceFDA RegulatoryMedical DevicesCommunicationTime Management

About the role

  • Familiarity with global medical device regulations (FDA QSR, ISO 13485, MDR, and/or MDSAP)

Responsibilities

  • Support maintenance of the Quality Management System (QMS) in compliance with FDA (21 CFR Part 820), ISO 13485, EUMDR, and global regulatory requirements
  • Assist with CAPA processes, including initiation, investigation support, tracking, and effectiveness verification
  • Participate in internal audits and support external inspections (FDA, Notified Bodies, MDSAP) including audit readiness activities
  • Maintain quality documentation in accordance with Good Documentation Practices (GDP)
  • Product compliance and regulatory documentation support

Requirements

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • Ability to work cross-functionally in a regulated environment

Nice to have

  • Assist with tracking, investigation, and closure of audit nonconformities
  • UDI data generation, verification, and maintenance (e.g., GUDID, EUDAMED)
  • Assist with the training program by tracking training requirements and ensuring QMS compliance
  • Bachelor's degree in Engineering, Life Sciences, or related technical field preferred
  • Associate degree or technical certification with relevant experience may be considered
  • Internship, co-op, or academic exposure to quality systems strongly preferred
  • Familiarity with CAPA, audits, nonconformance management, and Good Documentation Practices (GDP) preferred

Skills

  • Knowledge, Skills and Abilities
  • Effective written, verbal, and interpersonal communication skills

Compensation

  • $60,000.00 to $70,000.00
  • Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate.
  • For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.

Benefits

  • Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Company info

  • ZOLL is a fast-growing company that operates in more than 140 countries around the world.
  • Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit.

Equal opportunity

  • All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.
Apply directly at Zollmedicalcorp →Create a free account for alerts like thisView Zollmedicalcorp immigration profile

This listing is sourced directly from Zollmedicalcorp's careers page and normalized into a canonical job model.