Quality Assurance Engineer 3
Newark, DE, United States
Are you a seasoned quality professional ready to make a meaningful impact? Join us as a Quality Engineer 3 and play a pivotal role in ensuring our products meet the highest standards of quality, safety, and regulatory compliance.
Key Responsibilities: - Design and implement quality assurance protocols for our world-class products.
- Collaborate with Operations, Engineering, and R&D to ensure compliance with internal and external standards.
- Lead investigations, corrective actions, and quality improvement projects.
- Author technical reports, protocols, and complaints investigation documentation.
- Mentor and coach junior staff while promoting learning and development.
- Ensure compliance with FDA, ISO, and other regulatory standards.
Knowledge - In-depth understanding of quality management systems (QMS), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP).
- Familiarity with FDA and ISO regulations governing the medical device industry.
- Knowledge of manufacturing methodologies like Lean, Root Cause Analysis, and Six Sigma.
- Strong foundation in microbiology, molecular biology, biochemistry, and related scientific disciplines.
Skills - Excellent technical writing skills for quality assurance reports and procedures.
- Proficiency in statistical analysis, risk assessment, and troubleshooting techniques.
- Ability to execute analysis of large datasets and draw valid conclusions.
- Advanced computer skills, including word processing, spreadsheets, and databases.
- Expertise in nucleic acid amplification and detection technologies is a plus.
- Strong collaboration and interpersonal skills.
- Exceptional problem-solving and critical-thinking abilities.
- Ability to plan, prioritize, and manage multiple projects simultaneously.
- Effective communication skills, including presenting technical data to stakeholders.
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 technical discipline (e.g., Engineering, Life Sciences).
- 5-8 years of experience in quality assurance or a related field, or 2-5 years with an advanced degree.
- Experience with sterilization and cleanroom processes is a plus.
- Demonstrated expertise in compliance audits, corrective actions, and regulatory inspections.
- Background in project management and leading cross-functional teams.
Apply now to become our next Quality Engineer.
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 to $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.