Sr. Quality Assurance Engineer

Sr. Quality Assurance Engineer

Newark, DE, United States

Are you a quality-focused professional passionate about ensuring excellence in manufacturing and production processes? Join Hologic as a Senior Quality Assurance Engineer and play a critical role in designing, implementing, and maintaining quality assurance protocols that meet internal and external regulatory standards for worldwide distribution. In this role, you'll collaborate with cross-functional teams, lead quality initiatives, and drive continuous improvement to ensure the delivery of high-quality, innovative products that improve lives globally..

Knowledge

• In-depth understanding of quality management systems (QMS) and regulatory standards (e.g., GMP, GLP, ISO, FDA, Six Sigma).

• Strong knowledge of manufacturing, sterilization, and cleanroom processes.

• Familiarity with quality assurance methodologies such as Root Cause Analysis, Lean, Total Quality Management (TQM), and Statistical Process Control (SPC).

• Solid foundation in microbiology, molecular biology, biochemistry, chemistry, or related scientific disciplines.

• Expertise in nucleic acid amplification, detection technologies, and the scientific method for data analysis.

Skills

• Advanced technical writing and documentation skills to author quality assurance reports, procedures, and investigation protocols.

• Excellent electrical failure troubleshooting

• Strong analytical skills for evaluating large datasets, identifying trends, and drawing valid scientific conclusions.

• Proficient in quality improvement tools such as CAPA, HRA, HHE, MRB, and SCAR processes.

• Excellent project management skills with the ability to plan, prioritize, and execute multiple projects within deadlines.

• Proficiency with computer tools, including word processing, spreadsheets, and databases.

• Strong interpersonal and collaboration skills to work effectively with cross-functional teams, mentor junior engineers, and present findings to stakeholders.

• Working knowledge of FDA and ISO regulations governing medical devices is highly beneficial.

Behaviors

• Collaborative and team-oriented, with a commitment to working closely with stakeholders to understand their needs.

• Detail-oriented and meticulous in ensuring data accuracy and integrity.

• Proactive in identifying opportunities for innovation and continuous improvement in dashboard design and data analysis processes. Detail-oriented with a commitment to data accuracy, quality, and integrity.

• Proactive and innovative in identifying opportunities for process improvements and implementing best practices.

• Collaborative and team-oriented, with a focus on mentoring and coaching others to elevate team performance.

• Resilient and adaptable in managing challenges in a fast-paced, regulated environment.

• Demonstrates urgency and accountability in resolving quality issues and ensuring compliance.

Experience

• Bachelor's Degree in Electrical Engineering (preferred) with 2-5 years of experience, or Master's Degree with 1-3 years of experience, or PhD with 0-1 year of experience.

• Experience in troubleshooting electrical failures (PCB's, cable wire harness assemblies, microchips)

• Experience with sterilization and cleanroom processes is highly beneficial.

• Demonstrated experience in quality assurance, quality improvement methodologies, and regulatory compliance.

• Proven ability to lead moderate to complex quality projects, including risk management, defect investigations, and corrective actions

• Certified Quality Engineer (CQE) certification is a plus.

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 $94,000-$146,900 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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