Quality Systems Lead — GMP/ISO Audits

HR Recruiting Service; Boston (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

HR Recruiting Service is seeking a Quality Professional in Boston, Massachusetts, to maintain quality systems and ensure compliance with established standards. The ideal candidate will have extensive experience in ISO standards, regulatory audits, and supervisory roles.

The role demands a strong attention to detail and excellent communication skills to effectively present information and manage compliance. The candidate should hold a BS in a relevant scientific discipline and possess significant experience in a regulated environment.

Qualifications

• 5–8 years of experience as a Quality Professional in regulated medical devices or life sciences.
• 5 years previous supervisory experience, preferably in Quality Systems or Quality Assurance.
• Strong attention to detail in composing and proofing materials.

Responsibilities

• Develop and oversee the execution of the company’s audit plans and strategies.
• Ensure compliance with established company and regulatory standards.
• Host external regulatory agency assessments and inspections.

Skills

ISO 9001/13485

Validation

Audit experience

GMP environment

Interpersonal skills

Education

BS in Physical or Biological Sciences

Job description

HR Recruiting Service is seeking a Quality Professional in Boston, Massachusetts, to maintain quality systems and ensure compliance with established standards. The ideal candidate will have extensive experience in ISO standards, regulatory audits, and supervisory roles.

The role demands a strong attention to detail and excellent communication skills to effectively present information and manage compliance. The candidate should hold a BS in a relevant scientific discipline and possess significant experience in a regulated environment.