Quality Assurance Specialist - Device History Record (DHR)

Job Title

Quality Assurance Specialist - Device History Record (DHR)

Job Description

This individual ensures Device History Records meet regulatory and internal requirements and provide adequate verification of compliance to the product’s engineering specifications. 

Your role:

• The Quality Assurance Specialist is a member of the Operations Quality team in Latham which ensures compliance with legal, regulatory and international standards as they apply to Latham’s Quality Management System.  This role is critical in ensuring that manufacturing records for components of medical devices are compliant with applicable standards and regulations prior to releasing product from the factory. 

• The employee reviews electronic and paper records to ensure completeness, accuracy and compliance to defined specifications and requirements.  Nonconformances are identified and corrected prior to allowing shipment of product from the facility.

• This position reports into the Quality Management System Manager.  The employee will work directly with Operations, Quality Engineer and Quality Control teams to make sure information is accurately and completely recorded, and corrected, as needed.

• This employee will have the opportunity to work closely with other Quality, Manufacturing and Design Engineers on a site that has led innovation in the design of magnets for Magnetic Resonance Imaging (MRI) systems.  This position requires the employee to be on site five days per week.

You're the right fit if:

• You’ve acquired 1+ years of experience in medical device or a regulated industry, preferred.

• Your skills include proficiency in Good Documentation Practices (GDP) along with a general understanding of ISO 9001, ISO 13485, FDA CRF 21 part 820 and Good Manufacturing Practices (GMP).  Must be proficient with Microsoft Office applications; experience with eQMS (Trackwise, EtQ) and ERP (SAP) software desired. 

• You have a Technical Diploma, or Bachelor or Associates Degree in engineering science, or equivalent work experience. 

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

• You’re an individual with strong communication skills including written, verbal and listening; and have excellent organizational skills with the ability to multi-task and effectively prioritize your workload.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

• Read more about our employee benefits.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips Transparency Details

The hourly pay range for this position is $20.36 to $34.90, plus overtime eligible.  The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. 

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found