🌎
This job posting isn't available in all website languages
📁
Regulatory & Quality Assurance
📅
2174 Total Views

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.


Summary of Duties and Responsibilities

  • Oversees and monitors the inspection and testing of materials, parts, and products to ensure adherence to established quality standards.
  • Provides manufacturing support through supervision, training and guidance of Receiving Inspectors, Final and In-Process Inspectors to ensure compliance with product specifications, Food and Drug Administration’s GMPs and ISO.
  • Ensures timely scheduling of raw material inspection, product inspection, auditing and data collection.
  • Works with Engineering, Manufacturing Engineering and Quality Engineering to develop control plans such as inspection plans, first articles, and process validation.
  • Works with Engineering, Manufacturing Engineering and Quality Engineering in the development, implementation and training of acceptance activities (e.g. receiving, in-process and final inspection) based upon the criticality of design and product specifications.
  • Works with Engineering, Manufacturing Engineering and Quality Engineering to develop and train QC personnel in inspection protocols/techniques and equipment usage.
  • Provides feedback to Engineering, Manufacturing Engineering and Quality Engineering regarding specifications of materials, parts and products based upon inspection results.
  • Formulates and revises quality control policies and procedures as necessary.
  • Meet production schedule to max efficiency and timeliness, within assigned budget.
  • Establishes applicable statistical methods within the Quality Control acceptance activities such as process capability and sampling.
  • Provides direction to QC staff regarding facilitation of nonconforming events (NCE), material review boards (MRB), containment and disposition of nonconforming events (NCE).
  • Supports Quality Engineering and Manufacturing Engineering regarding NCE investigations and related corrective actions.
  • Works with Procurement to facilitate return of NCE material to suppliers.
  • Maintain clean, safe working environment.
  • Provide written and oral performance reviews for all assigned personnel.
  • Adheres to and supports the company policy and QSR/ISO Quality System requirements.
  • Provides performance management and development for QC personnel.

Qualifications
  • Minimum of 5 years supervisory or management experience. 
  • Well-established computer, communication & presentation skills are essential. 
  • Requires mechanical aptitude and knowledge of geometric dimensions, as well as demonstrated ability to read and understand written specifications. 
  • Strong interpersonal skills with a proven record of accomplishments in Quality Control.
 

Education   

  • Bachelor degree preferred
 
Experience 
  • 5-10 years related experience
  • Experience with Oracle a plus.
 

Specialized Knowledge

  • Comprehensive knowledge of ISO 9001 & 13485 standards, FDA Quality System regulations and Good Manufacturing Practices.
  • Comprehensive knowledge of Quality Control techniques such as sampling plans, metrology, technical mathematics, inspection equipment, measurement systems analysis, drawings/specifications, statistical process controls, etc.
  • Certified Quality Inspector certification 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. 


Previous Job Searches

Please try again.

Oops!

Either there was a problem on our end with the action you just performed, or we are currently having technical difficulties with our system. Please try again later.