Quality Assurance Analyst II - 1819

SRG; Braintree (MA); On-site; USD 62,000 - 83,000; Full time

Job summary

Impellam Group is seeking a Senior Specialist, Quality Assurance for an on-site contract in Braintree, MA. You will lead complex QA activities, review batch records and DHRs, and mentor staff while ensuring compliance with QMSR, 21 CFR Part 820, ISO 13485, and cGMP.

Responsibilities include product disposition, nonconformance investigations, audits, risk management, and preparing QA metrics. Strong documentation and cross-functional collaboration are required.

Qualifications

• Bachelor's degree in a science, engineering, quality, or related discipline.
• 5-7 years of experience in Quality Assurance and/or Regulatory Compliance.
• Proficiency in QMSR / 21 CFR Part 820, ISO 13485, cGMP, and Good Documentation Practices.
• Experience reviewing batch records, DHRs, and product disposition and release.
• Experience supporting nonconformance, investigation, and CAPA activities.
• Experience with change control and validations (process, test method, equipment).
• Experience conducting internal and external audits.
• Knowledge of Design Controls.
• Proficiency with Microsoft Office and database systems.
• Strong written/verbal communication and ability to work cross-functionally.
• Comfort working in cleanroom conditions and PPE.

Responsibilities

• Independently review and approve batch records and DHRs for compliance.
• Perform in-process quality reviews and cleanroom observations.
• Support product disposition and release processes.
• Provide advanced support for nonconformance investigations and CAPAs.
• Support complaint investigations and post-market surveillance.
• Review and approve validation/qualification docs and support validations.
• Assist risk management activities including pFMEA and updates.
• Write and revise quality system procedures and controlled documents.
• Lead document control, change control, supplier quality, and audit readiness.
• Compile and present quality metrics and prepare management review materials.
• Support FDA inspections and internal/external audits; train staff.

Skills

Quality assurance

Regulatory compliance

Audits

Documentation practices

Risk management

Independent work

Cleanroom gowning

Education

Bachelor's degree in science/engineering/quality

Associate degree with equivalent experience

Tools

Microsoft Office

Database systems

Job description

Senior Specialist, Quality Assurance (Contract)

Braintree, MA | On-site | Contract (approx. 6 months) | $30-40/hr | 7 openings

About the Role

Be the quality voice on the floor. As a Senior Specialist, Quality Assurance, you'll work with minimal supervision on complex QA activities: reviewing and approving batch records and DHRs, supporting product disposition and release, and providing in-process quality oversight in the cleanroom. You'll also mentor junior QA staff and represent Quality in cross-functional work with Manufacturing, Engineering, and Quality Control.

All work is performed in line with QMSR (21 CFR Part 820), ISO 13485, and cGMP requirements.

What You'll Do

• Independently review and approve batch records and Device History Records (DHRs) for compliance and completeness
• Perform in-process quality reviews and approvals of critical manufacturing steps, and conduct cleanroom observations and risk-based spot checks
• Support and coordinate product disposition and release
• Provide advanced support for nonconformance investigations, CAPAs, root cause analysis, and effectiveness checks
• Support complaint investigations and post-market surveillance
• Review and approve validation and qualification documentation, and support process, test method, and equipment validations
• Support risk management activities, including pFMEA development and updates
• Write, review, and revise quality system procedures, forms, and controlled documents
• Lead activities in document control, change control, supplier quality, training compliance, and audit readiness
• Compile, analyze, and present quality metrics, and help prepare Quality Management Review materials
• Support and host portions of FDA inspections, internal audits, and external audits
• Train quality and manufacturing personnel, and mentor and coach junior QA staff
• Drive continuous improvement of the Quality Management System

What You Bring

Required

• Bachelor's degree in a science, engineering, quality, or related discipline (or an associate degree with equivalent relevant industry experience)
• 5-7 years of experience in Quality Assurance and/or Regulatory Compliance
• Demonstrated proficiency in QMSR / 21 CFR Part 820, ISO 13485, cGMP, and Good Documentation Practices
• Experience independently performing batch record review, DHR review, and product disposition and release
• Experience supporting nonconformance, investigation, and CAPA activities in a regulated environment
• Experience with change control and supporting process, test method, or equipment validations
• Experience conducting or supporting internal and external audits
• Working knowledge of Design Controls
• Proficiency with Microsoft Office and database systems
• Strong written and verbal communication, and the ability to work independently and cross‑functionally
• Comfort working in cleanroom conditions and gowning into PPE

What will help you succeed

• Strong attention to detail across multiple simultaneous assignments
• Ownership mindset, with sound risk‑based decision‑making
• Flexibility when priorities shift, including additional hours when operations require it

Details

• Location: On-site in Braintree, MA
• Type: Contract, approximately 6 months
• Pay: $30-40/hr
• Openings: 7

Impellam Group and its brands are equal‑opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre‑employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting [e-mail] or fill out this form to request accommodations.