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Engineer

Company: Apex Systems
Location: Lowell
Posted on: November 18, 2020

Job Description:

APEX SYSTEMS is seeking a Quality Engineer to work for a client of ours in the Medical Device industry for more information please send your resumes directly to Cassie Mosqueda at Quality Engineer I - Complaint Investigation Job Description We are seeking a high caliber Quality Engineer I to conduct complaint investigation management and all activities pertaining to product complaints for Mechanical Circulatory Support devices. This includes, but is not limited to Receiving and investigating reports of worldwide complaintsevents Entering information into the complaint database Supporting filing and response to medical devices reports with various regulatory agencies Participating on cross-functional teams Providing information on product complaints, including data extracted from the complaint database to various teams (e.g. Regulatory, Quality Engineering) This QE 1 role will also have the opportunity to expand development in the area of quality engineering methodologies and providing quality engineering support within new product development, manufacturing, manufacturing transfers, andor systemservices support. Responsibilities Communicates verbally and in writing both internally and externally regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file Investigates complaintsevents in a timely manner Maintains accurate entry of complaints in database Records condition of returned products including observations, photographs Coordinates product testinganalysis with other departments and external consultants Prepares technical reports of analysisfindings Works collaboratively with cross-functional groups (e.g. QEs, RD) on evaluation trends or findings Interprets technical product specifications, Device History Records, or measurements obtained Utilizes safe bio-hazard and chemical handling practices at all times Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, rapid customer response team, Risk Management meetings) Leads the investigation, resolution and prevention of product and process non-conformance Participates in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) Leads in the completion and maintenance of risk analysis Other Duties Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors Performs other related duties and responsibilities, on occasion, as assigned. Qualifications BS degree in Biomedical or Mechanical Engineering 0-2 years' experience Knowledge of global regulations for medical device reporting and medical terminology is a plus Strong written and oral communication skills are required Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously. EEO Employer Apex 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 EEO Employer Apex 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

Keywords: Apex Systems, Lowell , Engineer, Other , Lowell, Massachusetts

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