12 Aug
Quality Engineer
New Hampshire, Nashua , 03060 Nashua USA

Vacancy expired!

Job#: 1283875

Job Description: Apex Systems is seeking a Quality Engineer to join our client working in the medical device industry. This is a full time, permanent position and will be working onsite in Nashua, NH. The client is a smaller company with great culture, benefits, and work-life balance.For immediate consideration, please send a copy of your resume to Justin Trible at and reference Job ID #1240482.Summary:As a Quality Engineer, you will work to improve the quality of products and processes while operating in a culture highly receptive to quality with the objective of doing the right thing. You will have the opportunity to support and provide guidance to the adherence of processes and procedures in order to maintain safety, efficacy and quality of our products and compliance with applicable standards and regulations.Duties and Responsibilities:
  • Assigned to processes and projects of moderate to high complexity, perform compliance assessments, make decisions regarding quality and regulatory requirements; ensures adherence to current regulations.
  • Team participant assigned to projects related to quality initiatives and compliance improvements.
  • Author new and revise existing operating procedures and test or inspection protocols and reports.
  • Perform impact assessments, root cause analysis, identification and implementation of appropriate corrective actions and preventative actions.
  • Perform statistical analysis/trend problem reporting data to support the site (e.g. yield improvements, CAPA, complaint and scrap reduction).
  • Contribute to continual process improvement by participating in site projects.
  • Facilitate risk assessments, FMEAs for new product introduction, and take appropriate actions during quality oversight activities to ensure adequate controls in relation to the level of product quality, safety and business risks.
  • Create/maintain and/or remediate Design History Files and Risk Management Files.
  • Perform Supplier Change Evaluations, Internal Change Evaluations, Product Quality Reviews, Customer Notifications, Field Action activities.
  • Participate in new product development activities to ensure the smooth transfer from development to production.
  • Support other activities within the Quality Management System as required.
  • Other duties as assigned.
Preferred Qualifications:
  • Working knowledge of industry standards (e.g. ISO 13485, ISO 14971, ISO 11135, ISO 60601, etc.)
  • Ability to work independently or as part of a team, self- motivated, adaptable
  • Excellent communication skills both verbal and written
  • Strong attention to detail
  • Proactive
  • Bachelor's Degree in an Engineering discipline from an accredited college or university
  • Minimum four years' experience in medical device industry or another highly regulated field; or equivalent combination of education and experience.
  • Knowledge of Food and Drug Administration (FDA) Part 820
  • Knowledge of EU MDD/MDR and other applicable country directives and regulations
#LI-JD10EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

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