Quality Engineer 2

Hologic•Marlborough, MA

13d

About The Position

Are you passionate about ensuring the highest quality standards for life-saving medical devices? At Hologic, we are seeking a Quality Engineer II to drive compliance, risk management, and continuous improvement across our product lifecycle. In this role, you’ll collaborate with cross-functional teams to lead investigations, implement corrective actions, and support design transfers while leveraging your expertise in regulatory compliance and quality systems. If you’re a proactive problem-solver with a strong commitment to operational excellence and customer satisfaction, this is your opportunity to make a meaningful impact on healthcare innovation. Knowledge: In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, ensuring regulatory compliance and product quality. Strong understanding of risk management principles, including ISO 14971 and PFMEA, to support design transfer and production processes. Familiarity with statistical tools and methodologies such as Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE). Proficient in Quality Management Systems (QMS), data analysis tools, and enterprise software systems. Skills: Proven ability to lead Nonconforming Events (NCE) investigations and CAPA teams to identify root causes, implement sustainable solutions, and maintain compliance. Strong technical writing skills for preparing and reviewing technical reports, validation documentation, and quality records. Analytical skills to compile, interpret, and act on quality system metrics and product quality data to drive improvements. Ability to facilitate design transfers and manage seamless product transitions between sites during New Product Introduction (NPI). Proficient in developing and maintaining process FMEAs throughout the production lifecycle. Strong communication and collaboration skills to work effectively across teams and with stakeholders. Behaviors: Ownership-driven, taking accountability for deliverables and maintaining a proactive approach to resolving quality issues. Collaborative and team-oriented, fostering partnerships to achieve shared goals and deliver exceptional results. Customer-focused, with a commitment to exceeding expectations and delivering innovative, high-quality solutions. Continuous improvement mindset, driving operational excellence and lean thinking across the organization. Detail-oriented and compliance-focused, ensuring adherence to regulatory standards, company policies, and best practices.

Requirements

Bachelor’s degree in a related discipline or equivalent combination of education and experience.
2–4 years of experience as a Quality Professional in the medical device industry or equivalent combination of education and experience.
Hands-on experience with investigations, CAPAs, and process validations (IQ, OQ, PQ).
Proven success in utilizing statistical tools and methodologies to analyze data and improve processes.
In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, ensuring regulatory compliance and product quality.
Strong understanding of risk management principles, including ISO 14971 and PFMEA, to support design transfer and production processes.
Familiarity with statistical tools and methodologies such as Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE).
Proficient in Quality Management Systems (QMS), data analysis tools, and enterprise software systems.
Proven ability to lead Nonconforming Events (NCE) investigations and CAPA teams to identify root causes, implement sustainable solutions, and maintain compliance.
Strong technical writing skills for preparing and reviewing technical reports, validation documentation, and quality records.
Analytical skills to compile, interpret, and act on quality system metrics and product quality data to drive improvements.
Ability to facilitate design transfers and manage seamless product transitions between sites during New Product Introduction (NPI).
Proficient in developing and maintaining process FMEAs throughout the production lifecycle.
Strong communication and collaboration skills to work effectively across teams and with stakeholders.
Ownership-driven, taking accountability for deliverables and maintaining a proactive approach to resolving quality issues.
Collaborative and team-oriented, fostering partnerships to achieve shared goals and deliver exceptional results.
Customer-focused, with a commitment to exceeding expectations and delivering innovative, high-quality solutions.
Continuous improvement mindset, driving operational excellence and lean thinking across the organization.
Detail-oriented and compliance-focused, ensuring adherence to regulatory standards, company policies, and best practices.