Elevate Quality and Customer Satisfaction as Our Senior Manager, Post-Market Surveillance !

 

Are you passionate about driving product excellence and enhancing customer satisfaction? We are looking for a dynamic and experienced Senior Manager, Post-Market Surveillance, to join our team and lead impactful quality evaluations and investigations.

 

What to Expect:

 

In this pivotal role, as the Senior Manager, Post-Market Surveillance, you will plan and direct activities related to product quality evaluations, investigations, and root cause analyses based on post-market feedback and field complaints. Your strategic vision will be key in setting and monitoring key performance indicators, ensuring that performance aligns with our high standards and taking necessary actions as required. By analyzing data and evaluating strategic impacts, you will effectively prioritize schedules to drive operational success.

 

As a leader focused on customer quality, you will build strong relationships with our sales and service teams, providing on-site support and ensuring our customers' needs are met. You will select, develop, and evaluate top talent to ensure the efficient operation of the function, fostering a culture of continuous improvement and excellence.

 

This role offers you the opportunity to make a significant impact by maintaining and elevating our product quality standards and enhancing customer satisfaction. If you have a keen eye for detail, a strategic mindset, and a passion for quality assurance, we want to hear from you. Join us and lead the charge in setting new benchmarks for quality and customer support. Apply today and be part of an exciting journey toward operational excellence!

 

 

What We Expect:

 

Responsible for managing team to build and maintain a compliance-based culture.  Oversees all activities related to investigation of product quality issues.  Ensures timely processing of complaints, including ensuring the accuracy of data collected and thorough investigation. Manage the timely analysis of data, development of investigation plans and execution of investigations to identify root cause(s). Drive engagement to ensure personnel have clear expectations, appropriate tools and information, an opportunity to share, grow and develop, and are recognized for their contributions. Provides support during inspections by regulatory bodies, with regards to documentation of product quality investigations.  Work closely with R&D, Manufacturing, Service, and Supplier Quality to ensure thorough and accurate investigations and drive the initiation of CAPAs when appropriate.  Lead and coordinate cross-functional product investigations, including driving product and process improvements Present trends from investigation findings and recommendations for improvement to management. Develop procedures/processes, tools, and techniques to aid in product investigations. Work closely with franchise teams to prioritize investigations.

 

 

Qualifications and Skills

 

Education     

 

Bachelor’s Degree, preferably in an engineering/scientific discipline, mechanical, electrical or equivalent (BSME, BSEE) May have Master’s Degree, May have PhD

 

Experience   

 

10+ Years with Bachelor’s Degree 7+ Years with Master’s Degree 5+ Years with PhD

 

Skills

Regulation 21 CFR Part 820, Part 803 and applicable international quality standards and regulations including ISO 13485:2016, Canadian MDR, and EU Medical Device Regulation  Prior management experience in a medical device, pharmaceutical or heavily regulated industry. Excellent problem solving and root cause analysis skills. Strong analytical skills including trend and statistical analysis, interpersonal, and management skills.  Strong leadership capabilities. Ability to develop and manage high performing engaged team and effectively manage cross-functional relationships and establish clear roles and responsibilities.  Familiarity with employee development and mentoring process. Demonstrates independent decision making and prioritization, including independent resolution of conflicts.

 

 Beneficial

 

Experience with Oracle & Agile PMP Certification Lean-Six Sigma Green or Black Belt Certification

 

 

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 131,400 -219,000 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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