Top 6 Quality assurance auditor Jobs in Topsfield, Ma

Auditor, Quality Assurance
LeMaitre —Burlington, MA
- $75,000 - $85,000 a year
- Full-time
- Nursing
- Mid-level
- High school diploma or GED
- Opportunities for advancement
Clinical Quality Assurance Pharmacist – Pharmacy Claims Audit Review - Hybrid
Integrated Pharmacy Solutions —Melrose, MA
- $60 - $65 an hour
- Part-time
- Hybrid work
- 5 years
- Office
- Senior level
Quick Apply
3d
Senior Manager, Corporate Quality – R&D Audits
Sarepta Therapeutics —Bedford, MA
- $136,000 - $170,000 a year
- Full-time
- Hybrid work
- 5 years
- Bachelor's degree
- Travel
6437 - Senior Quality Engineer / Senior Quality GxP Auditor
Verista, Inc. —Boston, MA
- $70,491 - $113,521 a year
- Engineering
- 3 years
- Master's degree
- Commuter assistance
- Paid parental leave
Quick Apply
Quality Auditor
The Charles Stark Draper Laboratory, Inc. —Cambridge, MA
- $75,000 - $156,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- 3 years
Quick Apply
7d

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Commercial Lines Quality Assurance Senior Specialist (hybrid/remote)
Grange Insurance Company —Columbus, OH
Through its network of independent agents, Grange offers auto, home and business insurance protection. To foster an inclusive environment, we are intentional in…
6d
Quality Process Manager Systems & Audits
Vertiv —Westerville, OH
If you're passionate about driving continuous improvement, partnering with manufacturing teams, and transforming quality into a competitive advantage, we'd love…

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quality assurance auditor jobs near topsfield, ma

Auditor, Quality Assurance

LeMaitre -
Burlington, MA

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Job Details

Full-time
$75,000 - $85,000 a year

Benefits

Opportunities for advancement

Qualifications

Optimizing workflow processes
Nursing
Stakeholder engagement
Safety regulations
Regulatory compliance
Mid-level
Incident Escalation
High school diploma or GED
Analysis skills
Records management
Continuous improvement
Serology
Decision making
Quality improvement
Bachelor of Science in Nursing
Health record chart audits
Biomedical regulatory compliance
Bachelor's degree in nursing
LPN
Quality audits
Cross-functional collaboration
Escalation handling
2 years
Healthcare compliance
Documentation review
Quality control records management
Communication skills
Cross-functional communication
FDA regulations
Documentation reviews

Full Job Description

Overview:

This role is responsible for reviewing and assessing the medical suitability of human cardiovascular tissue donors for transplant. The position ensures compliance with FDA regulations, AATB standards, Good Tissue Practices, and the company’s Quality Management System.

Responsibilities:

Conduct comprehensive quality reviews of all records generated during tissue recovery, processing, cryopreservation, labeling, storage, and distribution, ensuring accuracy and completeness.
Evaluate medical documentation, including donor charts, autopsy reports, EMS records, serology, and culture reports, to determine donor eligibility and medical suitability for transplant.
Engage with recovery partners and other stakeholders to request clarifications, obtain additional documentation, and resolve discrepancies in donor records.
Ensure adherence to the company’s Quality Management System (QMS), FDA 21 CFR Part 1271 Good Tissue Practices, AATB standards, and internal policies and procedures.
Identify and escalate issues that may impact compliance, safety, or product quality, providing input to management for investigation, corrective actions, and process improvements.
Collaborate with cross-functional teams to streamline workflows, improve record accuracy, and enhance operational efficiency.
Perform additional responsibilities as assigned by management to support departmental and organizational objectives.

Qualifications:

High School diploma. LPN, RN, or BSN related clinical experience preferred.
Minimum of 2 years’ experience in quality assurance or a regulated healthcare/biotech environment preferred.
Experience reviewing medical records, donor charts, or clinical documentation a plus.
Knowledge of FDA regulations (21 CFR Part 1271), AATB standards, and Good Tissue Practices is highly desirable.
Strong analytical and problem-solving skills, with the ability to make informed decisions and escalate issues appropriately.
Excellent oral and written communication skills, with the ability to collaborate effectively with internal teams, external partners, and regulatory stakeholders.
Flexible, adaptable, and open to change, with a demonstrated willingness to accept responsibility and drive process improvements.

Pay range $75,000-$85,000 per year plus bonus. The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education, qualifications, certifications, experience, and other job-related factors permitted by law.

EEO Statement:

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.

This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.

Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at [email protected].

Apply Now

Refine Your Search

quality assurance auditor jobs in topsfield, ma

Auditor, Quality Assurance

Clinical Quality Assurance Pharmacist – Pharmacy Claims Audit Review - Hybrid

Senior Manager, Corporate Quality – R&D Audits

6437 - Senior Quality Engineer / Senior Quality GxP Auditor

Quality Auditor

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