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Sr Quality Engineer/Scientist - Merrimack, NH

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Date: Jan 14, 2022

Location: Merrimack, NH, US

Company: Getinge

 

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

 

 

Job Overview

The  Senior Quality Engineer/Scientist (with chemicals/materials science background) primarily serves as a cross-functional team member between the Design Quality Engineering (DQE) and Materials Science/Biocompatibility groups. The individual will be responsible to provide guidance and direction for quality activities ensuring GMP, ISO 10993, and other regulations compliance supporting the analytical, material science, and biocompatibility documentation and laboratory procedures. The individual will review and approve the implementation of materials science/biocompatibility-related policies, procedures, and testing protocols/reports to comply with Getinge quality system, standards, and regulations. Additional activities may include to resolve critical and/or complex compliance issues, ensuring testing procedures are aligned with global quality standards and regulatory expectations, assuring data integrity with paper based and electronic processes, overseeing implementation of risk-based strategies, ensuring analytical/material science lab is inspection ready at all times, and interacting with FDA and other regulatory/health agencies when necessary.

This position may also serve as a member on collaborative cross-functional teams, , to support new product development efforts, material-related design changes, supplier changes, and manufacturing and process changes, risk management activities, and other compliance projects involving materials science aspects, such as EU MDR uplift of existing products.   

The main function of the DQE team is to ensure compliance to internal procedures and external regulations, standards, and guidances, and ensure design controls are met throughout the lifecycle of our devices. You will also provide SME input for risk management.  You will ensure best practices are followed in documentation and design decisions to support successful audits by regulatory agencies. This role consists mainly of review of analytical, material science laboratory SOPs, instrumentations, documentation and collaborative cross-functional team discussion and decision making.

 

Flexible work hours and work-from-home options are available; however, the position is expected to have ability to be onsite as determined by business needs.

 

Job Responsibilities and Essential Duties

  • Ensure compliance with applicable Getinge standards and regulatory guidelines (e.g. ISO 10993 and 21 CFR Part 11).
  • Evaluate and approve risk assessments, excursions, and deviation investigations (e.g. OOS, invalid testing results).
  • Evaluate verification and validation laboratory/testing protocols and reports to ensure compliance to external standards and internal standards and procedures.
  • Review/approve standard operating procedures, methods validations, specifications, protocols and reports, instrument acquisitions/decommissions, work orders, as applicable.
  • Ensure processes are harmonized across multiple Getinge laboratories
  • Serve as key quality resource in lead teams and/or other forums as required and provide compliance guidance to laboratories and other supporting business units.
  • Collaborate with cross-functional departments during planning and process/continuous improvement projects and initiatives to ensure timely completion (e.g. lab quality plans objectives and milestones).
  • Provide quality oversight for analytical/material science testing/technology transfers to and from Getinge Atrium facilities.
  • Ensure data compiled is communicated in relevant forums and escalate compliance issues to Quality senior management.

 

Minimum Requirements

  • Bachelor’s or Master’s Degree in Engineering, Chemistry or Biological Sciences or equivalent work experience, or Ph.D. with 2 years of experience.
  • A minimum of five years related med device or pharma manufacturing experience in a QMS environment. 
  • A minimum of five years related experience in lab quality engineer or quality assurance manufacturing and medical device environment.
  • Excellent oral communication and technical writing skills
  • Computer skills, including MS Office applications (Word/Excel) and statistical software are required.
  • Strong project management, prioritization and leadership skills are required.

 

Required Knowledge, Skills and Abilities

  • Knowledge of Laboratory Quality Assurance methods, such as test method and instrumentation validation, design of experiments, statistical process control (SPC) and protocol/report preparation. 
  • Knowledge of Biocompatibility ISO 10993 and FDA requirements and how they relate to biological safety risk assessment, testing, and other quality practices
  • Good analytical and problem solving skills. 
  • High level of attention to detail and accuracy.
  • Demonstrated ability to motivate multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Excellent analytical and problem solving skill combined with strong technical presence. 
  • Firm understanding of Quality System Regulations, i.e. ISO 13485, 11607, 14971, 10993, IEC 62304, and other recognized international quality system standards, and how they relate to design control, risk management, and other quality practices. 

 

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

 

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We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.

 

 


Nearest Major Market: Manchester
Nearest Secondary Market: Nashua