Quality Assurance Engineer 3 at Hologic in Marlborough, MA, United States

Job description

• Are you passionate about ensuring the safety and reliability of life-saving medical devices? At Hologic, we are seeking a Quality Assurance Engineer – Product Quality to play a critical role in managing product holds, stop ships, corrections, and field actions. In this role, you’ll develop and maintain Quality Management System (QMS) procedures, collaborate with cross-functional teams, and drive process improvements to ensure compliance and efficiency. If you’re detail-oriented, proactive, and eager to contribute to the continuous improvement of product quality, this is your opportunity to make a meaningful impact in the healthcare industry.

Responsibilities

• Managing product holds, stop ships, corrections, and field actions.
• Developing and maintaining Quality Management System (QMS) procedures.
• Collaborating with cross-functional teams.
• Driving process improvements to ensure compliance and efficiency.

Requirements

• Strong understanding of Quality Management Systems (QMS) and regulatory requirements, including field action management, product holds, and stop ships.
• Familiarity with FDA regulations, ISO 13485 standards, and corrective/removal action processes.
• Knowledge of product lifecycle management systems and best practices for tracking quality records.
• Expertise in root cause analysis methodologies and corrective action processes.
• Proven ability to develop, implement, and maintain QMS procedures and work instructions for product holds, stop ships, and corrections/removals.
• Strong organizational skills to plan, execute, and monitor field actions, recalls, and corrective actions.
• Effective communication skills to liaise with corporate process owners, external vendors, and cross-functional teams.
• Technical writing skills for documenting progress, tracking closure of records, and creating training materials.
• Ability to conduct complex investigations and provide clarity into root cause findings.
• Proficiency in identifying process improvements and recommending enhancements to quality systems.
• Experience in providing training, guidance, and ongoing support to ensure proper utilization of quality tools and systems.
• Proactive and detail-oriented, ensuring timely execution of quality processes and compliance with regulatory requirements.
• Collaborative and team-oriented, building strong partnerships across functions to drive results.
• Problem-solving mindset, with a focus on continuous improvement and operational efficiency.
• Results-driven, with the ability to manage escalations and adverse trends effectively.
• Adaptable and resilient, thriving in a fast-paced, regulated environment.
• 2-4 years in Quality Assurance, Project Management or Customer Service roles in a medical device or related regulated industry.
• Hands-on experience with field actions, product holds, stop ship processes, and corrective/removal activities.
• Proven track record of supporting QMS initiatives, including integration and process improvements.
• Experience conducting complex investigations and implementing corrective actions.
• Familiarity with cross-functional collaboration on quality improvement projects.

Skills

Required

• Strong organizational skills
• Effective communication skills
• Technical writing skills

Benefits

• The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.