SENIOR QUALITY ASSURANCE ENGINEER

MedAcuity, LLC; Westford, Northern (MA, KY); Hybrid; USD 125,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

HRA

FSAs

401(k) with company match

Life and disability insurance

Voluntary life insurance

Employee assistance programs

Recognition awards

Vacation and sick time

Job summary

MedAcuity, LLC is seeking a Senior Quality Assurance Engineer to join our MedTech-focused teams. You will audit and improve QMS processes, develop vital quality documentation, and drive compliance across design and development artifacts.

You will collaborate with internal and client teams, lead risk analyses, CAPAs, and training to ensure alignment with 21 CFR Part 820, ISO 13485, and ISO 14971, while supporting audits and continuous quality improvements.

Qualifications

• 8+ years in QA/regulatory in medical device with software focus.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, IEC 62304, IEC 81001-5-1, and ISO 14971.
• Experience with QMS improvements, documentation, and DHF gap analysis.
• Production QA in medical device/pharma regulated fields.
• Experience communicating with internal/external stakeholders.
• Proficiency with CAPAs and root cause analysis.

Responsibilities

• Lead and audit QMS elements across design and development artifacts.
• Develop and improve SOPs, VMPs, Verification and Validation Plans, Risk Management Plans, and CAPAs.
• Ensure compliance with 21 CFR Part 820, ISO 13485, risk management.
• Provide QA regulatory support to teams and clients.
• Lead risk analysis and CAPA processes.
• Deliver training materials for engineers and leadership.
• Support internal and external audits.

Skills

QA / Regulatory experience

Software process compliance

Root Cause analysis

CAPA management

Education

Bachelor's degree in CS/EE or related

Tools

eQMS

MasterControl

Arena

Veeva

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.

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