Quality Assurance Specialist - Device History Record (DHR)

Quality Assurance Specialist - Device History Record (DHR) Job Description Quality Assurance Specialist – Device History Record 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 CFR 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. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 5 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office role. Philips Transparency Details The pay range for this position in Latham, NY is $24.51 to $34.53 Hourly. The actual base pay offered may vary within the posted ranges 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. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Latham, NY.

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Equal Employment and Opportunity Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. #J-18808-Ljbffr Philips Iberica SAU