Quality Assurance Engineer

Quality Assurance Engineer

Newark, DE, United States

Are you passionate about ensuring the safety, reliability, and compliance of life-saving medical devices? At Hologic, we are seeking a Quality Engineer to support the design, manufacturing, and quality assurance of medical devices. In this role, you will apply quality protocols, perform inspections, investigate non-conformances, and drive continuous improvement initiatives to uphold our commitment to excellence. If you're detail-oriented, eager to learn, and ready to contribute to a team focused on delivering high-quality products, we encourage you to apply and be part of our mission to improve lives worldwide.

Knowledge:

• Working knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485, and Medical Device Directive (MDD).

• Familiarity with risk management practices, including risk assessments and documentation updates.

• Understanding of quality systems investigations, including QSI, NCE, and MRB processes.

• Awareness of technical developments in the medical device industry through publications and research.

• Knowledge of inspection procedures, test methods, and regulatory requirements for medical devices.

Skills:

• Strong computer skills, including proficiency in word processing, spreadsheets, and databases.

• Excellent technical writing skills for drafting quality assurance reports, procedures, and documentation.

• Analytical skills to read, interpret, and apply technical procedures, professional journals, and government regulations.

• Effective presentation skills to communicate findings and resolutions across teams.

• Good interpersonal skills to interact with all levels of the company, even in adversarial situations.

• Ability to perform audits of facilities and suppliers for compliance with requirements.

• Technical proficiency in facilitating processes like ECOs, engineering studies, and design verification/validation.

Behaviors:

• Detail-oriented and committed to maintaining accuracy and compliance in all tasks.

• Proactive and adaptable, with a focus on identifying and resolving quality issues urgently.

• Collaborative and team-oriented, fostering strong relationships across departments.

• Problem-solving mindset, leveraging root cause analysis and corrective actions to address challenges.

• Dedicated to continuous improvement, driving process enhancements and reducing variation or waste.

• Customer-focused, ensuring that products meet regulatory standards and exceed expectations.

Experience:

• Technical Bachelor's Degree preferred, or equivalent work experience in a related field.

• 0-2 years of experience in quality assurance or manufacturing roles with a non-technical degree.

• 0-1 year of experience with a technical or advanced degree in engineering or a related field.

• Hands-on experience with quality management systems and compliance audits preferred.

• Exposure to clean rooms, controlled environments, and manufacturing processes is beneficial

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $62,900-$98,400 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 Notice

Agencies 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.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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