Hologic Manager/Sr Manager, Quality Assurance in Sunnyvale, California

Manager/Sr Manager, Quality Assurance

Post Date Oct 29, 2018

At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.

Job Summary:

Responsible for maintaining and improving Quality Management System to comply with applicable regulations for the site.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Manages and maintain of the Site’s the Quality Management System (QMS) and its respective processes

  • Ensure the QMS meets all applicable regulatory requirements and standards.

  • Serves as the site Management Representative

  • Develops Quality metrics and goals; lead efforts related to the company’s quality vision

  • Sets goals and strategic objective for the Quality organization

  • Develops, manages, implements, and monitors effectiveness of improvement projects

  • Manages the Site CAPA, non-conforming material, audit, deviation, validation, calibration, supplier quality, risk management and other quality-related processes and systems

  • Establishes SOPs and site procedures as needed

  • Manages the training program

  • Trains personnel in required tasks

  • Performs audits (internal, supplier, distributor, etc.)

  • Represent the site in external/3rd party audit such as ISO and FDA

  • Interacts with suppliers to enhance product quality

  • Sits on core team for new product development projects.

  • Interacts with R&D to ensure Products are developed in accordance with QSR and cGMPs

  • Takes part in testing and troubleshooting if necessary

  • Oversees customer complaints and Medical Device Reporting, when applicable.

  • Understands company manufacturing processes

  • Manages and coordinates the activities of a section or department with responsibility for results in terms of costs, methods and personnel

  • Performs root cause analysis investigations

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.

  • Excellent communication and organizational skills

  • Works on problems of complex scope where analysis of situation or data requires evaluation of identifiable factors and risks

Education:

BS/MS degree or equivalent experience in scientific discipline with thorough knowledge of GMP and Quality control concepts

Experience:

  • Minimum 3-5 years quality assurance/control experience

  • 3-5 years in management

  • Lab or other technical experience preferred.

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.