Senior / Lead Quality Assurance Engineer

Job Title: Senior / Lead Quality Assurance Engineer

Job Description

The Senior / Lead Quality Assurance Engineer coordinates and oversees batch record review and related production quality activities to support compliant and efficient medical device manufacturing operations. This role serves as the primary lead for Device History Record (DHR) and batch record review coordination, product release support, review prioritization, issue escalation, and cross-functional alignment with Manufacturing, Quality Engineering, Quality Control, Materials Management, and Operations. The position provides technical leadership, mentorship, and operational coordination to ensure inspection readiness, continuous improvement, and right-first-time execution across manufacturing quality processes, while maintaining adherence to domestic and international quality system standards and regulations.

Responsibilities

• Coordinate and oversee batch record review and associated production quality activities to support compliant and efficient medical device manufacturing operations.
• Serve as the primary lead for Device History Record (DHR) and batch record review coordination, ensuring timely and accurate completion of documentation.
• Lead product release support activities, including review prioritization and alignment with production schedules and business needs.
• Manage review prioritization and issue escalation to ensure timely resolution of documentation and compliance issues.
• Align cross-functionally with Manufacturing, Quality Engineering, Quality Control, Materials Management, and Operations to support smooth and compliant production activities.
• Drive timely resolution of production quality issues, including documentation errors, deviations, and nonconformances.
• Support nonconformance, CAPA, deviation, change control, and investigation activities in a regulated manufacturing environment.
• Monitor quality metrics and review performance, using data to identify trends, risks, and opportunities for improvement.
• Ensure adherence to FDA Quality System Regulation (21 CFR Part 820), ISO standards, Good Documentation Practices, and applicable global regulatory requirements.
• Support inspection readiness activities and contribute to successful internal, external, customer, and regulatory audits as needed.
• Promote continuous improvement initiatives focused on right-first-time execution, backlog reduction, and review cycle-time improvements.
• Provide technical leadership and mentorship to junior QA staff, offering guidance on batch record review, DHR processes, and production quality best practices.
• Collaborate with cross-functional partners to identify and mitigate quality risks, escalate issues appropriately, and drive corrective and preventive actions.
• Utilize electronic Quality Management Systems (eQMS) and ERP/MES systems to manage quality records, track actions, and support quality operations.
• Track and report quality metrics using Microsoft Office applications, including Excel, to support management reviews and operational decision-making.
• Demonstrate ownership and accountability for operational quality performance while maintaining composure and sound decision-making in high-pressure production environments.

Essential Skills

• Bachelors degree in Life Sciences, Engineering, Quality, Biotechnology, Chemistry, Microbiology, or a related discipline.
• Minimum 5+ years of experience in Quality Assurance, Manufacturing Quality, or Operations Quality within the medical device, in vitro diagnostics, biotechnology, or regulated healthcare industry.
• Minimum 2+ years of experience coordinating batch record review, DHR review, product release activities, or manufacturing quality operations.
• Demonstrated experience working within FDA 21 CFR Part 820 and applicable global regulatory requirements.
• Experience supporting nonconformance, CAPA, deviation, change control, and investigation activities in a regulated manufacturing environment.
• Experience partnering cross-functionally with Manufacturing, Quality Control, Supply Chain, Engineering, and Operations teams.
• Strong understanding of batch record review, Device History Record (DHR) review, and product release processes.
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO standards, and Good Documentation Practices.
• Ability to coordinate high-volume review activities while managing competing priorities and production schedules.
• Strong problem-solving and investigation skills with attention to detail and compliance risk assessment.
• Ability to identify trends, escalate quality risks appropriately, and drive timely resolution of production quality issues.
• Strong organizational and coordination skills in fast-paced manufacturing environments.
• Effective communication and collaboration skills with the ability to influence cross-functional teams without direct authority.
• Ability to mentor junior QA staff and provide technical guidance to peers and manufacturing partners.
• Proficiency with Microsoft Office applications, including Excel for metrics tracking and reporting.

Additional Skills & Qualifications

• ASQ Certification such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent quality certification, preferred.
• Experience supporting internal, external, customer, or regulatory audits.
• Experience within In Vitro Diagnostics (IVD), molecular diagnostics, or complex reagent/instrument manufacturing environments.
• Experience driving continuous improvement initiatives, right-first-time improvements, backlog reduction, or review cycle-time improvements.
• Experience working within electronic Quality Management Systems (eQMS) and ERP/MES systems such as SmartSolve, Agile, SAP, Oracle, or MasterControl.
• Demonstrates ownership and accountability for operational quality performance.
• Drives urgency and execution while maintaining compliance standards.
• Promotes continuous improvement and operational efficiency.
• Builds strong partnerships across Manufacturing and Quality functions.
• Maintains composure and sound decision-making in high-pressure production environments.
• Great opportunity for a lead-level engineer seeking to develop and enhance leadership and management skills.

Work Environment

The role is based in a medical device manufacturing environment that operates under strict regulatory and quality system requirements. The position involves close collaboration with Manufacturing, Quality Engineering, Quality Control, Materials Management, Supply Chain, and Operations teams in a fast-paced, production-focused setting. Work is supported by electronic Quality Management Systems (eQMS) and ERP/MES platforms such as SmartSolve, Agile, SAP, Oracle, or MasterControl, along with standard office productivity tools like Microsoft Office. The environment emphasizes inspection readiness, continuous improvement, and right-first-time execution, with a strong focus on compliance, documentation accuracy, and cross-functional teamwork.

This is a Contract to Hire position based out of Wheeling, IL.

The pay range for this position is $50.00 - $60.00/hr.

Eligibility requirements apply to some benefits and may depend on your job

classification and length of employment. Benefits are subject to change and may be

subject to specific elections, plan, or program terms. If eligible, the benefits

available for this temporary role may include the following:

Medical, dental & vision

Critical Illness, Accident, and Hospital

401(k) Retirement Plan Pre-tax and Roth post-tax contributions available

Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Wheeling,IL.

This position is anticipated to close on Jun 12, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions.

We help visionary companies advance their engineering and science initiatives through

access to specialized experts who drive scale, innovation and speed to market.

With a network of almost 30,000 consultants and more than 4,500 clients across the U.S.,

Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without

regard to race, sex, age, color, religion, national origin, veteran status, disability,

sexual orientation, gender identity, genetic information or any characteristic protected

by law.

If you would like to request a reasonable accommodation, such as the modification or

adjustment of the job application process or interviewing process due to a disability,

please email ... for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the

city and county of San Francisco, we will consider for employment qualified applicants

with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a

condition of employment or continued employment. An employer who violates this law

shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process,

including sourcing, screening, and evaluating candidates. AI helps assess applications

and qualifications, but final decisions are made by our hiring team. By applying, you

acknowledge and agree that your application may be reviewed using AI tools.