QA MANAGER- Healthcare

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

Small company, the Quality team is made up of the manager and one associate, we need someone very good with rolling up their sleeves.

Job Description

The successful candidate will be responsible for maintaining the quality systems strategy and providing coordination and direction of existing quality programs to ensure production of products, services, and processes are consistent with established standards.

Essential Duties

• Developing and overseeing execution of the company’s audit plans and strategies.
• Process and evaluate audit findings to monitor overall compliance and identify quality-related trends, issues, business or regulatory risk areas, and training needs.
• Provide consultation on regulatory compliance issues.
• Ensure performance and quality of products and services conform to established company and regulatory standards.
• Host external regulatory agency and notified body assessments and inspections (example: FDA, ISO). Review and participate in issues and/or decisions related to assessments.
• Serve as the site management representative, providing updates to the company and the VP of Bioservices regarding status of the quality system, compliance status and performance related to quality.
• Maintain the biological and chemical waste management programs to ensure compliance with Local, State and DOT regulations.
• Act as a customer interface during on-site audits, conference calls and other standard means of communication.

Qualifications

• BS in Physical, Biological Sciences, or a technical/scientific discipline.
• Experience with ISO 9001/13485.
• Experience with validation.
• Experience guiding or managing the CAPA and NCR process.
• Experience in a pharmaceutical or life sciences organization.
• Experience leading FDA/ISO audits.
• Experience in a GMP environment.
• CLIA experience helpful.
• 5–8 years (maximum 8) of experience as a Quality Professional in a regulated medical device, in vitro diagnostics, or life science industry.
• 5 years previous supervisory experience, preferably in Quality Systems or Quality Assurance.
• American Society for Quality certification desirable.
• In-depth knowledge and application of regulations, guidelines and industry practices and the ability to interpret the regulations and guidelines.
• Ability to effectively present information to management, regulatory agencies and other departments.
• Experience interpreting and complying with cGMP, CLIA, IVDD or MDD, working.
• Excellent interpersonal, communication, analytical, managerial, and organizational skills.
• Strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.

Additional Information

All your information will be kept confidential according to EEO guidelines.