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Quality Assurance Engineer 2

Newark, DE, United States

Are you a seasoned quality professional ready to make a meaningful impact? Join us as a Quality Engineer 2 and play a pivotal role in ensuring our products meet the highest standards of quality, safety, and regulatory compliance.

Key Responsibilities:

+ Design, implement, and maintain quality assurance protocols for medical devices.

+ Collaborate with Operations, Engineering, and R&D to ensure compliance with regulatory standards and customer expectations.

+ Investigate and resolve quality issues with urgency, conducting root cause analysis and corrective actions.

+ Develop and deliver training on quality procedures and inspection methods.

+ Actively participate in audits, regulatory inspections, and continuous improvement initiatives.

+ Prepare reports and documentation to assess and improve the quality system.

Knowledge

+ Understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

+ Familiarity with medical device regulations (21CFR820, ISO 13485, MDD) and FDA standards.

+ Knowledge of microbiology, molecular biology, biochemistry, chemistry, or related scientific disciplines.

+ Awareness of nucleic acid amplification and detection technologies is a plus.

+ Knowledge of Oracle and Agile systems is beneficial.

Skills

+ Proficiency in creating quality assurance reports, procedures, and technical documentation.

+ Strong analytical skills for statistical analysis, risk assessments, and problem-solving.

+ Ability to conduct customer complaint investigations and root cause analysis.

+ Experience with technical writing and presenting data effectively.

+ Excellent interpersonal skills to work collaboratively across departments.

+ Strong presentation skills for communicating results and progress effectively.

+ Ability to prioritize, manage time, and handle multiple projects efficiently.

+ High attention to detail and commitment to accuracy and precision.

Behaviors

+ Proactive and self-driven with a commitment to continuous improvement.

+ Detail-oriented with a focus on precision and accuracy.

+ Collaborative team player with a willingness to mentor and coach others.

+ Resilient and able to act with urgency to resolve quality issues.

+ Open to learning and staying updated on industry trends and developments.

Experiences

+ Bachelor’s degree in a technical discipline (e.g., Engineering, Life Sciences).

+ 2–5 years of experience in quality assurance or related roles.

+ Experience in an FDA-regulated industry is beneficial.

+ Exposure to audits, inspections, and compliance processes.

+ Background in implementing and improving quality systems is preferred.

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 $76,800 to $120,100 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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