Quality Assurance Engineer 3
Hologic Careers
Summary
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.
Job description
Knowledge
- 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.
Skills
- 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.
Behaviors
- 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.
Experience
- 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.
Requirements
- 2-4 years in Quality Assurance, Project Management or Customer Service roles in a medical device or related regulated industry
- Strong understanding of Quality Management Systems (QMS) and regulatory requirements
- Familiarity with FDA regulations and ISO 13485 standards
- Expertise in root cause analysis methodologies and corrective action processes
- Hands-on experience with field actions, product holds, stop ship processes, and corrective/removal activities
- Proven ability to develop, implement, and maintain QMS procedures and work instructions
- Strong organizational skills to plan, execute, and monitor field actions, recalls, and corrective actions
- Effective communication skills to liaise with cross-functional teams and external vendors
- Technical writing skills for documentation and 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 on quality tools and systems
Benefits
- Comprehensive training
- Career development
- Bonus eligible
Company overview
Hologic, Inc. is a leading global medical technology company founded in 1985 and headquartered in Marlborough, Massachusetts. The company specializes in developing and manufacturing innovative diagnostic products, medical imaging systems, and surgical solutions with a particular focus on advancing women's health and well-being. Hologic operates across three core business segments: Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions. The company's mission is to enable healthier lives everywhere, every day through science-based certainty in early detection and treatment. Hologic is renowned for its clinically superior products that help detect, diagnose, and treat illnesses earlier and more effectively, with a strong emphasis on women's health issues including breast cancer, cervical cancer, and gynecological conditions. The company employs approximately 5,000-10,000 professionals globally and maintains a significant presence in the medical technology sector, consistently pushing the boundaries of innovation in healthcare diagnostics and treatment solutions.