Sr. Manager, Quality Assurance - Technical Investigation

San Diego, CA, United States

Job Summary:

The Senior Manager of Quality is responsible for leading and managing the technical investigation team to ensure high-quality standards and compliance with regulatory requirements. This role involves overseeing the investigation of product complaints, maintaining the turn-around time of complaint investigations, driving the risk management process to implement corrective and preventive actions (CAPAs), and driving continuous improvement initiatives within the organization. This position entails managing and supporting the team's development and may assist, where needed, in any site-specific post-market process.

Key Responsibilities:

Leadership and Management:

• Responsible for strategic workforce planning, developing and implementing employee communication and training programs in connection with Hologic quality objectives, strategies, and processes

• Lead and manage a team of (Scientists and Engineers for Sustaining Product scope) quality technical investigation, providing guidance, mentorship, and performance evaluations.

• Grows talent within the organization by leading employee development initiatives to create a high-impact team to execute tactical and strategic imperative.

• Develop metrics and measurable goals for the respective team members.

• Identifies resource needs and facilitates Allocation of resources, resolution of resource conflicts, and business justifications and trade-offs related to resource utilization.

Technical Investigation:

• Oversee the investigation of product quality issues from the field, deviations, and non-conformances.

• Coordinate with cross-functional teams to identify root causes and implement practical corrective and preventive actions (CAPAs).

• Ability to complete a Health Hazard Evaluation (HHE) and ultimately lead a risk discussion with a clinician and product subject matter expert.

• Responsible for quality technical investigation summary of Adverse event reporting to ensure compliance

• Trend, analyze, and report on quality data to improve product and process; develop recommendations based on data analyses and ensure corrective actions are appropriate to the risk level.

• Advocates strategically and operationally effective solutions to complex problems

Quality Assurance and Compliance:

• Ensure compliance with regulatory requirements, industry standards, and company policies.

• Develop and maintain documentation related to quality investigations, CAPAs, and continuous improvement initiatives.

• Lead Product Quality committee meetings/ discussions as and when needed to review release product issues that may potentially affect safety, clinical performance, and global compliance and determine course of action as applicable.

• Serves as key quality technical investigation subject matter expert during 3 rd party audits and inspections and in external customer interactions.

• Ability to utilize external sources of technical information to incorporate into risk assessments to meet IVDR “State of the Art” requirement.

Stakeholder Collaboration and Continuous Improvement:

• Collaborate with customer service, Quality complaint team, manufacturing, engineering, research and development, and other departments to address quality issues and implement improvements.

• Communicate investigation findings, CAPAs, and improvement plans to senior management and stakeholders with a concise action plan.

• Effectively manage cross-functional relationships and establish clear roles and responsibilities to drive accountability.

• Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve overall efficiency by demonstrating and promoting a culture of continuous improvement by utilizing LEAN and Six Sigma methodologies.

Qualifications:

Education:

• Bachelor’s degree in Biology, Chemistry, Engineering, Life Sciences, or a related field. A Master’s degree or PhD is preferred.

Experience:

• BS and 10+ years related experience or MS and 6+ years or PhD and 4+ years related experience in quality assurance, technical investigation, or a related field.

• Experience in regulated industries such as IVD, medical devices, or biotechnology.

• Strong execution knowledge of QMS systems, FDA regulations, ISO 13485, MDD / IVDD / IVDR / MDR/ ISO14971

• Strong background in root cause analysis, Risk Management, FMEA, Health Hazard Evaluation, Complaint, change control, CAPA management, and continuous improvement methodologies.

• Demonstrated change management experience, guiding the organization to the desired state.

Skills:

• Excellent analytical and problem-solving skills.

• Strong leadership and team management abilities.

• Exceptional communication, written, and interpersonal skills.

• Attention to detail and a solid commitment to maintaining high-quality standards.

• Understanding nucleic acid amplification and detection technologies, scientific method, and statistical analysis.

• Experience with all aspects of NAAT manufacturing, such as oligonucleotide synthesis, bulking/filling/lyophilization, packaging, and shipping with manual / semi-automated and automated processes, as applicable is Plus

• Enterprise mindset that can break down silos. Ability to bring people together to work towards the same purpose across organization boundaries. Track record in leading teams directly or indirectly in multicultural and matrix environments.

Additional Requirements:

• Ability to manage multiple projects and deadlines.

• Strong organizational and time management skills.

• A proactive approach to identifying opportunities for quality improvements and innovations.

• Willingness to travel as required for technical investigations at customer site

• Adaptable to fast-paced, dynamic work environments with shifting demands

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 134,400 -196,000 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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