Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, and treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, and mini C-arm for extremity imaging .
The primary role of this position will be to perform the review of product device history records (DHR’s) and to release product to finished goods.
Essential Duties and Responsibilities
Ø Performs detailed review of device history record documentation as part of in-process and final inspection/release activities for finished products.
Ø Communicates to Engineering when device history documentation changes are needed.
Ø Provides support to manufacturing personnel to ensure proper documentation of Failure Investigation Reports and that all Non-Conforming Materials are processed correctly (properly identified, quarantined, documented and processed out of the area).
Ø Constantly educates and trains manufacturing employees on best practices for completing inspection reports and compilations of Device History Records.
Ø Conducts preliminary reviews on new releases of inspection and test documents that will eventually end up as part of the Device History record. This will ensure documents are clear and easy to complete.
Ø Maintains QC Activity Collection Plan and sends out applicable reports as assigned.
Ø Supports Quality Control team as needed with quality related activities.
Ø Responsible to maintain Device History Records which includes activities such as filing, scanning, providing copies to other groups when requested etc.
Ø Supporting external and internal audits as it relates to the final release process.
Ø Other duties as assigned.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ø Very high level of attention to detail specifically when it comes to reviewing documentation.
Ø Outstanding organization skills.
Ø Excellent communication skills.
Ø Ability to work independently with minimal supervision.
Ø Strong computer skills (Email, Word, Excel etc.).
Ø High school degree and or an equivalent of technical school education and/or equivalent inspection training. Experience
Ø 2 years of on-the-job experience working in Quality in a medical device or a closely related field
Ø Extensive GMP/FDA and/or ISO knowledge
Ø Willing to undergo additional professional training in quality related topics and be ASQ Certified as applicable.
Ø Experience with Oracle, Agile and TrackWise preferred but not required. Specialized Knowledge
Hologic corporation is a developer, manufacturer and supplier of diagnostic and medical imaging systems related to women's health. It...