SENIOR QUALITY ASSURANCE ENGINEER

MedAcuity; Lowell (MA); On-site; USD 125,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental and vision insurance

401(k) matching

Life and disability insurance

HRA and FSA

Job summary

MedAcuity, Inc. seeks a Senior Quality Assurance Engineer for the MedTech space, focusing on remediating legacy quality systems and ensuring compliant project execution. You will audit processes, develop QMS procedures, and align with 21 CFR Part 820, ISO 13485, and ISO 14971 standards.

The role includes CAPA processing, risk analysis, and cross-functional training, with competitive compensation and comprehensive benefits.

Qualifications

• Bachelor's degree in a STEM field or equivalent experience in a regulated quality environment.
• 8+ years in QA/regulatory within medical devices or software-enabled devices.
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with CAPA processes, corrective actions, and risk management.

Responsibilities

• Lead or participate in quality management system assessments related to medical device software.
• Author and improve QMS documents, SOPs and project quality plans.
• Ensure conformance to Design Controls, Risk Management (ISO 14971) and related standards.
• Support internal and external audits and regulatory inspections.
• Perform root cause analysis and drive CAPA execution across teams.
• Develop training materials for engineering, quality and leadership audiences.
• Collaborate with project teams and clients to ensure compliant project execution.
• Provide QA/regulatory technical support to product development and service activities.

Skills

Regulatory compliance

CAPA

Root Cause Analysis

Quality Assurance

Software validation

Education

Bachelor's degree in Computer Science

Bachelor's degree in Electrical Engineering

Tools

MasterControl

Arena

Veeva

eQMS

Job description

Company Overview

We are MedAcuity, Inc. We partner with leading product development companies to develop life and mission-critical software bringing the highest levels of Service and Value to every engagement. Through our consulting and development engagements, we bring the best and brightest talent to our clients, applying deep technical knowledge, business acumen, and innovative solutions to complex engineering problems and constructing aligned solutions for our clients. Our approach forges long-term, collaborative relationships with clients enabling them to focus on their own core competencies in Medical Devices, Robotics, and Aerospace / Defense Equipment.

Job Summary

The Senior Quality Assurance Engineer will work closely with internal and external project teams, cross-functionally throughout the project life cycle primarily in the MedTech space. The candidate will be adept at remediating legacy quality systems, and ensuring consistent, compliant project execution. They will be responsible for auditing processes, developing and improving QMS procedures, and ensuring alignment with regulatory and industry standards.

Responsibilities

• Contribute to or lead assessment engagements for medical device products in terms of completeness, conformance, and compliance as it relates to a Quality Management System (QMS) and associated QMS elements and Design and Development File and associated design artifacts.
• Author, remediate, and improve QMS elements including SOPs and Wis as well as project specific documents such as Quality Management Plans, Verification and Validation Plans, Risk Management Plans, and CAPAs.
• Partner with project teams and clients to ensure conformance to requirements of 21 CFR Part 820, ISO 13485 with particular focus on Design Controls, Risk Management (per ISO 14971), Production, Service Controls, Product Privacy, and Security.
• Provide teams with technical support for QA / Regulatory compliance activities.
• Participate in CAPA processes, risk analysis, complaint management, and internal auditing.
• Identify, develop, and execute process improvements, lead continuous improvement initiatives and drive changes cross-functionally.
• Develop and deliver effective training materials tailored to engineering, quality, and leadership audiences.
• Support internal as well as external audits and other Quality Assurance functions.

Qualifications

• 8+ years of professional background in a similar QA / Regulatory function within a medical device environment with a focus on software process compliance.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, IEC 62304, IEC 81001-5-1 and Risk Management standard ISO 14971.
• Experience with QMS improvements, documentation authoring, and DHF gap analysis.
• Production expertise in software development and Quality Assurance in medical device, pharmaceutical, or related regulated fields.
• Exposure to working in a professional services environment, communicating with primary stakeholders from internal consultancy and client management.
• Proficiency with Root Cause analysis and Corrective Actions (CAPAs).

Preferred Skills

• Certified Quality Engineer preferred and / or Auditor Certification desired.
• Proficiency in cyber-security regulations and its integration with risk management activities.
• Direct experience with requirements development, analysis, verification, and validation.
• Prior work history with software tools such as eQMS and document control systems such as Master Control, Arena, Veeva, etc.

EDUCATION

• Bachelor's degree in Computer Science, Electrical Engineering, or other STEM related fields OR equivalent experience in a comparable role.

A realistic estimate of starting base salary for this full-time position is $125,000 to $150,000. The actual salary offered may vary based on work location, experience, education, training, external market data, internal pay equity and other business considerations. This position qualifies for a discretionary performance based bonus based on personal and company factors. We also offer a comprehensive benefit program including medical, dental and vision insurance, a Health Reimbursement Arrangement (HRA), Flexible Spending Accounts, 401(k) with company match, company paid life and disability insurance, additional voluntary life insurance, employee assistance programs and recognition awards. Our leave programs include competitive vacation and sick time allowances, company holidays, and a healthy work life balance is a priority here.

Applicants for employment at MedAcuity, LLC are considered without regard to race, color, religion, sex, sexual orientation, gender-related identity/appearance, pregnancy, age, genetic information, national origin, status as a Vietnam Era or disabled veteran or membership in the uniformed services, physical or mental disability, or any other legally-protected classification.

MedAcuity is an equal opportunity employer.

MedAcuity is a leading software engineering firm solving complex challenges for mission critical industries, including medical devices, healthcare technology, robotics, and other high reliability, regulated markets. With deep expertise across embedded systems, application development, and cloud solutions, we deliver high integrity, high performance software that powers life saving technologies and next-gen innovation. We believe great engineering starts with great people. Our culture values technical excellence, curiosity, and collaboration, thriving at the intersection of innovation and safety, speed and precision. If you're excited to build software that drives real impact, join us in shaping the future of technology in healthcare and beyond.