Director, Quality Management Systems

At Hologic Inc., we’re on a mission to innovate and enhance patient care through cutting-edge medical devices. Based in Newark, DE, we thrive in a fast-paced and collaborative environment. If you’re passionate about quality and love tackling challenges head-on, we want you on our team!

We're seeking a dynamic Director, Quality Management Systems to join our fantastic team. You'll be the go-to person for developing, implementing, and maintaining our quality assurance and control systems. You’ll work closely with various departments to ensure our products are precise, accurate, and reliable. Plus, you'll be our liaison with the FDA and manage communications regarding audit findings with external regulatory agencies.

What You’ll Be Doing:

• Lead Quality Initiatives: Take charge of our overall Quality Management System, including management controls, production, process controls, and more.
• Liaison with FDA: Manage all communications with the FDA and other regulatory agencies regarding audit findings.
• Promote Quality Programs: Develop and implement employee communication and training programs to highlight our quality objectives and strategies.
• Direct the Quality Team: Set goals, provide daily support, and give regular feedback to your team. Help with organizational and individual development plans.
• Recruit and Manage: Recruit, retain, and manage multiple direct reports. Handle performance management, employee development, mentoring, and coaching.
• Strategy and Improvement: Develop strategies for continuous improvement of the Quality Management Systems, including new product introductions and facility transfers.
• Compliance Assurance: Ensure our quality management systems comply with FDA regulations, ISO 13485, and other internal requirements.
• Management Review: Promote awareness of our Quality Policy and QMS, presiding over Quality Management Review meetings.
• Audit Management: Manage audits/inspections with Notified Bodies and the FDA, develop responses to corrective actions, and conduct follow-up audits.
• Data Analysis: Oversee measurement, analysis, and improvement programs to drive continuous improvement.
• Training Program: Develop and maintain a training program to ensure adherence to quality system procedures.
• Stay Updated: Keep up with industry developments by reviewing technical publications and participating in relevant training.

Experience/Qualifications:

• Education:
  • Preferred: BA/BS Degree
  • Technical/Advanced Degree: Master’s Degree preferred
• Experience:
  • Strong project management skills, warning letter and 483 experience highly desired.
  • Comfortable communicating with regulatory agencies with a proven track record.
  • 12 years with a non-technical degree, 10 years with a Master’s Degree, or 8 years with a PhD.
  • Experience in an FDA-regulated industry, especially with complex electronic, electro-mechanical, or software imaging medical devices.
  • Experience managing a Quality department and hosting/supporting third-party audits.
• Skills:
  • Advanced knowledge of QMS systems and electronic documentation management systems.
  • Leadership abilities with experience in employee engagement and talent development.
  • Excellent understanding of medical device Quality Systems Regulations (21CFR820), ISO 13485, and MDSAP requirements.
  • Strong technical writing, report writing, and presentation skills.
  • Excellent interpersonal and communication skills.
  • Proficient in Microsoft Office and databases.
  • Knowledge of device regulatory affairs is a plus.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $150,900 - $268,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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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