What are the responsibilities and job description for the Engineer, Quality position at TalentBurst?
Job Description
Job Description
Title: Engineer, Quality
Duration: 3 Months
Location: Scarborough, ME 04074
The position of Quality Investigation Engineer is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will have responsibility for supporting nonconformance and corrective and preventive action (CAPA) coordination and investigation. The role will provide support for product quality assurance, process improvements and all quality system programs at the Scarborough Site.
This job description will be reviewed periodically and is subject to change by management.
RESPONSIBILITIES:
Nonconformance (QI) and CAPA program:
Track Non-Conformance records to ensure the timely closure of all records.
Provide guidance to owners of investigations on performing investigations and in the use of Root Cause Analysis Tools.
Manage corrective and preventive actions to ensure timely closure of actions resulting from various types of investigations.
Provide metrics as requested to track/trend Non-Conformances, Deviations, and CAPAs.
Act as the lead for Non-Conformance impact assessments and investigations as needed.
Perform the closure of Effectiveness Checks. Manage the Effective Checks to ensure they are completed by the required due date.
Provide training on the use of Agile PLM, on performing investigation, and performing root cause analysis as needed.
Assist during regulatory inspections or other audits as required
Other duties as required
BASIC QUALIFICATIONS | EDUCATION:
BS in Engineering, Chemistry, Bio-Technology, Life Science or related discipline or equivalent combination of education and experience.
3 - 5 years of experience in manufacturing within a regulated industry, preferrably within the medical device industry.
Experience with and understanding of quality management systems, preferrably within the medical device industry.
Excellent quantitative and analytical skills (including use of statistical software).
Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel
PREFERRED QUALIFICATIONS:
Familiar with federal and other regulations, e.g. QSR's, ISO 13485, CMDR, IVDD/IVDR
Familiarity with modern ERP systems, PLM systems and/or manufacturing documentation (e.g., BOM, item masters, etc.)
Proficient using the Agile PLM system.
Strong analytical, verbal communication and writing skills.
Ability to work in a team environment as well as independently and with minimal supervision.
Ability to communicate in writing clearly and concisely, using grammatically correct sentence structure.
Skilled in tasks associated with document handling, archiving and change management.
Strong attention to detail and accuracy.
Strong time management, organizational, and prioritization skills.
Ability to effectively manage multiple projects and priorities.
Ability to interface professionally at all levels of the organization.
The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required. Essential Duties and Responsibilities: Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review. Complete final acceptance activities. Manage the sterilization process, including validations and product sterile loads. Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned product. Manage corrective action and quality improvement activities. Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.
Title: Engineer, Quality
Duration: 3 Months
Location: Scarborough, ME 04074
The position of Quality Investigation Engineer is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will have responsibility for supporting nonconformance and corrective and preventive action (CAPA) coordination and investigation. The role will provide support for product quality assurance, process improvements and all quality system programs at the Scarborough Site.
This job description will be reviewed periodically and is subject to change by management.
RESPONSIBILITIES:
Nonconformance (QI) and CAPA program:
Track Non-Conformance records to ensure the timely closure of all records.
Provide guidance to owners of investigations on performing investigations and in the use of Root Cause Analysis Tools.
Manage corrective and preventive actions to ensure timely closure of actions resulting from various types of investigations.
Provide metrics as requested to track/trend Non-Conformances, Deviations, and CAPAs.
Act as the lead for Non-Conformance impact assessments and investigations as needed.
Perform the closure of Effectiveness Checks. Manage the Effective Checks to ensure they are completed by the required due date.
Provide training on the use of Agile PLM, on performing investigation, and performing root cause analysis as needed.
Assist during regulatory inspections or other audits as required
Other duties as required
BASIC QUALIFICATIONS | EDUCATION:
BS in Engineering, Chemistry, Bio-Technology, Life Science or related discipline or equivalent combination of education and experience.
3 - 5 years of experience in manufacturing within a regulated industry, preferrably within the medical device industry.
Experience with and understanding of quality management systems, preferrably within the medical device industry.
Excellent quantitative and analytical skills (including use of statistical software).
Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel
PREFERRED QUALIFICATIONS:
Familiar with federal and other regulations, e.g. QSR's, ISO 13485, CMDR, IVDD/IVDR
Familiarity with modern ERP systems, PLM systems and/or manufacturing documentation (e.g., BOM, item masters, etc.)
Proficient using the Agile PLM system.
Strong analytical, verbal communication and writing skills.
Ability to work in a team environment as well as independently and with minimal supervision.
Ability to communicate in writing clearly and concisely, using grammatically correct sentence structure.
Skilled in tasks associated with document handling, archiving and change management.
Strong attention to detail and accuracy.
Strong time management, organizational, and prioritization skills.
Ability to effectively manage multiple projects and priorities.
Ability to interface professionally at all levels of the organization.
The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required. Essential Duties and Responsibilities: Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review. Complete final acceptance activities. Manage the sterilization process, including validations and product sterile loads. Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned product. Manage corrective action and quality improvement activities. Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.
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