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Job Requirements of Quality Engineer II:
-
Employment Type:
Contractor
-
Location:
Mansfield, MA (Onsite)
Do you meet the requirements for this job?
Quality Engineer II
Careers Integrated Resources Inc
Mansfield, MA (Onsite)
Contractor
Job Title: Quality Engineer II
Location: Mansfield, MA
Duration: 6+ Months(temp to perm)
Responsibility:
Location: Mansfield, MA
Duration: 6+ Months(temp to perm)
Responsibility:
- Primary function of the role is to address the backlog of Complaints that resulted from resource issues.
- This role supports maintenance and continuous improvement of the Complaint System, ensuring compliance with regulations and internal site and global procedures.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Ensure that all complaint investigations are performed, documented, and managed in a timely and efficient manner in accordance with all applicable internal procedures.
- Escalate relevant information on product complaints to appropriate management as necessary.
- Coordinate and/or attend meetings with appropriate departments for specific customer complaint issues.
- Plan, coordinate and execute the onboarding training of new complaint associates.
- Assess, process and close complaints in accordance with associated complaint handling procedures and Customer Quality expectations.
- Maintain and organize complaint product retention program at the investigation site in accordance with internal procedures and applicable regulatory requirements.
- Author and conduct technical complaint evaluations and investigations, including failure analysis.
- Review quality and manufacturing records, including DHRs, Company, CAPAs, complaint records, failure analysis data and reports, and risk documentation as part of the overall complaint investigation process.
- Perform trending and risk analysis of received complaint investigations; determine if upper controls have been exceeded and evaluate risk to patient.
- Perform robust root cause analysis using appropriate technical skills, structured problem-solving methods, etc.
- Review complaint evaluations and investigations, including failure analysis.
- Establish, follow, maintain, and improve Quality Management System procedures, work instructions, and other processes related to areas of responsibility.
- Support and participate in Internal and External Audits as required.
- Ensure compliance with ISO 13485, MDD, 21 CFR 820, GMP, and other applicable regulations and standards related to area of responsibility.
- Provide Complaints data analysis for metric reviews as applicable.
- Support and participate in post-market surveillance (PMS) activities as required.
- Identify and implement opportunities for continuous improvement.
- Perform other quality systems related duties as directed by Supervisor.
- Bachelor’s degree in an Engineering discipline (ex. – Mechanical, Electrical, etc.) required with minimum of 2-5 years’ experience in a regulated (i.e.- Medical Device) industry. Relevant experience may be considered in lieu of a degree.
- Strong knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards related to Complaints and Complaint Handling.
- Strong verbal and written communication skills with the ability to communicate effectively at multiple levels of the organization.
- Demonstrated organizational skills with the ability to multitask, prioritize and meet deadlines.
- Must be able to read and write in English.
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