Job DescriptionAre 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.
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.
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.
Agency and Third-Party Recruiter NoticeAgencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
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