Quality Engineer - Hologic
Marlborough, MA
About the Job
Quality Engineer
Marlborough, MA, United States
Why Hologic?
Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.
Our innovations are designed to achieve exceptional clinical results, making it possible to detect, diagnose and treat illnesses and other health conditions earlier and more effective.
Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.
What to Expect:
The Service Quality Engineer is responsible for leading and implementing design and process changes to improve product performance, product reliability, service capabilities, and serviceability of existing products. This person will conduct in-depth root cause analysis and investigations on returned product. This position may also require supporting serviceability for new product development. The position requires frequent interfacing with R&D, Manufacturing, Quality, and Marketing to learn, understand, troubleshoot, and become SME for the existing install base.
Organizational Relationships : Works with Divisional personnel and Costa Rica personnel including R&D, Regulatory, Marketing, PMQA, Manufacturing Engineering, and Quality Engineering.
What we Expect:
+ Assess reported field problems, with a focus on out of box failure, to determine if process/product changes are required to improve reliability and serviceability
+ Conduct in-depth root cause analysis and investigations on returned products
+ Write, review, and validate updates to technical documentation (i.e. - trouble shooting guides, updates to user guides, IFUs and manuals), for use by in-house and field personnel, to properly use and maintain Hologic products.
+ Lead change control process for product improvement (process or design) including drawing update, perform testing and change control documentation.
+ Partner with Marketing and Tech Services to implement necessary training and communications
+ Drive design for reliability, serviceability and sustainability requirements for existing and/or acquired products
+ Own CAPAs and drive to resolution to eliminate compliance concerns
Education & Experience:
+ Bachelor’s Degree in Engineering or equivalent required, preferably electromechanical background
+ 5 plus years’ experience, preferably in medical device industry, as a Quality, Manufacturing or R&D engineer
Skills:
+ Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14970, Risk Management
+ Must possess the ability to work independently to resolve reported or discovered product issues, capable of critical thinking with analytical and problem-solving skills
+ Must be able to communicate effectively and convey complex theories and procedures to all levels in the organization; able to influence key stakeholders to drive improvements
+ Thrives in a fast-paced, collaborative environment
The annualized base salary range for this role is $94,000 to $146,900 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._
#LI-PR1
Marlborough, MA, United States
Why Hologic?
Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.
Our innovations are designed to achieve exceptional clinical results, making it possible to detect, diagnose and treat illnesses and other health conditions earlier and more effective.
Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.
What to Expect:
The Service Quality Engineer is responsible for leading and implementing design and process changes to improve product performance, product reliability, service capabilities, and serviceability of existing products. This person will conduct in-depth root cause analysis and investigations on returned product. This position may also require supporting serviceability for new product development. The position requires frequent interfacing with R&D, Manufacturing, Quality, and Marketing to learn, understand, troubleshoot, and become SME for the existing install base.
Organizational Relationships : Works with Divisional personnel and Costa Rica personnel including R&D, Regulatory, Marketing, PMQA, Manufacturing Engineering, and Quality Engineering.
What we Expect:
+ Assess reported field problems, with a focus on out of box failure, to determine if process/product changes are required to improve reliability and serviceability
+ Conduct in-depth root cause analysis and investigations on returned products
+ Write, review, and validate updates to technical documentation (i.e. - trouble shooting guides, updates to user guides, IFUs and manuals), for use by in-house and field personnel, to properly use and maintain Hologic products.
+ Lead change control process for product improvement (process or design) including drawing update, perform testing and change control documentation.
+ Partner with Marketing and Tech Services to implement necessary training and communications
+ Drive design for reliability, serviceability and sustainability requirements for existing and/or acquired products
+ Own CAPAs and drive to resolution to eliminate compliance concerns
Education & Experience:
+ Bachelor’s Degree in Engineering or equivalent required, preferably electromechanical background
+ 5 plus years’ experience, preferably in medical device industry, as a Quality, Manufacturing or R&D engineer
Skills:
+ Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14970, Risk Management
+ Must possess the ability to work independently to resolve reported or discovered product issues, capable of critical thinking with analytical and problem-solving skills
+ Must be able to communicate effectively and convey complex theories and procedures to all levels in the organization; able to influence key stakeholders to drive improvements
+ Thrives in a fast-paced, collaborative environment
The annualized base salary range for this role is $94,000 to $146,900 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._
#LI-PR1
Source : Hologic
