Sr Manager, Post Market Quality, Engineering

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

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

What to Expect:

In this pivotal role, 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:

• Build a customer facing quality engineering team that interacts with field teams and customers by participating in site visits, attending sales and service council meetings to engage in information sharing with field as well as follow-up on quality escalations 
• Own customer/field team facing quality communication include customer memos, quality updates to field teams etc.
• Lead quick root-cause and effective resolution to product quality issues, including ship hold and field actions while communicating regularly to key stakeholders.
• Ensures accurate and timely processing of complaints and adverse event reporting to appropriate regulatory bodies.
• Work closely with R&D, Manufacturing, Service, and Supplier Quality to deliver effective product quality improvements or fixes in an expedited manner. 
• Responsible for carrying out Health risk assessments on complaints, CAPAs/NCs, ship holds and recall decisions. 
• Provides support during inspections by regulatory bodies, with regards to documentation of product quality investigations, CAPAs, NCs and other post market matters. 
• Present trends from investigation findings and recommendations for improvement to management. Owner of post market quality data for responsible products. 
• Develop procedures/processes, tools, and techniques to aid in product investigations.
• Based on surveillance findings, collaborate with technical groups to identify product or process improvement opportunities; assist in establishing engineering priorities. 
• 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.
• Provide post market input to new product development teams to ensure key quality considerations are scoped in to future product design and testing 

Qualifications and Skills

Education and Experience   

• 8-10 years in medical device with a bachelor’s Degree, in an engineering/scientific discipline, mechanical, electrical or equivalent (BSME, BSEE).

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.
• 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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