Senior​/Lead Quality Assurance Engineer

Position: 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

* Bachelor's 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…