Job Details

Senior Quality Engineer

Company name
Hologic, Inc.

Location
Danbury, CT

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Senior Quality Engineer','170605','!*!Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. There has never been a more exciting time to join us. Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.  Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare. We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future.','!*!Overview

A Quality Engineer would work on a

range of products in Hologic’s Breast and Skeletal Health Division on product

systems that include digital imaging equipment.  You will work in a

multi-disciplinary group, contributing to the sustaining manufacturing of

Hologic’s innovative products focusing on the production and process controls

including capital equipment with both electrical systems and

software.   

 

Role

Provide quality engineering support

in the production of medical device products, and facilitate the application of

production and process controls including continuous improvement. Provide

quality engineering support to various manufacturing sites and contract

manufacturers when process changes are required.   

 

Essential Duties &

Responsibilities

Actively support production through the application of

risk management, production and process controls (including process

validation), test method validation and quality engineering tools.

Provide quality engineering expertise to maintain and

improve product quality by investigating customer complaints, analyzing

nonconforming material reports, partnering with Engineering, Operations

and Service on design transfers and process validations and partnering

with Supply Quality regarding supplier performance.

Participate as a member of the MRB and the

dispositioning of nonconforming product and components.

Monitor quality metrics (e.g. field, manufacturing and

inspection) and key process indicators to identify opportunities for

improvement and partners with Operations, Service and Engineering to drive

actions.  Identifies unacceptable trends and applies suitable

corrective action in order to meet strategic objectives.

Lead and/or participate in multi-departmental and

multi-site teams to implement product quality initiatives.

Support the implementation of design changes.

Lead and/or participate in manufacturing/supplier

transfer activities (planning, qualification, etc.)

Review and approve process validation test plans,

protocols and reports. Ensure validation results demonstrate compliance to

medical device standards.

Review test methods for quality of verification and

validation of the method.

Interact with Operations to ensure products are

manufactured in accordance with QSR, cGMP and ISO 13485:2003.

Assist in the design and implementation of policies and

procedures for verification and validation of processes and/or equipment.

Participate in product risk assessment efforts,

including process failure mode effect analysis, within product teams and

updates to existing product lines.

','!*!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.  Reasonable accommodations may be made

to enable individuals with disabilities to perform the essential

functions.    

Skilled in requirements analysis, including testable

and measurable specifications

Experience with test methods and standards for the

validation of manufacturing and test methods for medical device products

Skilled in test plan development and root cause failure

analysis

Skilled in quality engineering tools and disciplines

such as process design, production and process controls, quantitative

methods and tools, continuous improvement, etc. (e.g. Cost of Quality)

Good verbal (including presentation) and written

communication skills, especially technical report writing

Ability to effectively work on project teams

Ability to appropriately assess written design, process

and device documentation as the principle advocate for compliance

Preferred Skills/Qualifications

Working knowledge of the FDA Quality System

Regulation, ISO 13485, and the Medical Device Directive

Familiar with ISO 14971, experience in risk evaluation

techniques, such as FMEA, fault tree analysis or HACCP

Skilled in statistical methods and design of experiments

Experience utilizing standard root cause analysis tools

(5-Why, FTA, fishbone diagrams, etc.)

Manufacturing engineering or manufacturing quality

engineering experiences a plus

Certified Quality Engineer certification 

Education

BS in an engineering discipline, or AS and relevant experience

Experience:

3 - 8

years of engineering experience, preferably with capital equipment

including process validation

Strong working knowledge of production and process

controls in a regulated industry

Strong working knowledge of risk management for medical

device products

Experience with test methods and standards for the

validation of manufacturing of medical device products

Skilled in test plan development and root cause failure

analysis

Working knowledge of supplier quality management

 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 & VEVRAA Federal Contractor MON 

 ','United States-Connecticut-Danbury','','','','Regulatory and Quality Leadership','Full-time','Day Job','','Sep 12, 2017','Senior Quality Engineer

Company info

Hologic, Inc.
Website : http://www.hologic.com

Company Profile
Hologic, Inc. (Nasdaq: HOLX) is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems, and surgical products, with an emphasis on serving the healthcare needs of women throughout the world

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