Quality Engineer II - Integrated Resources, Inc
Tewksbury, MA 01876
About the Job
Job Title: Quality Engineer II
Location: Tewksbury, MA
Duration: 12+ Months With Possible Extension
Pay Range :$30 to $47/Hr. on W2
Job Description:
Description of Work:
Minimum Qualifications:
Skills/Experience:
Location: Tewksbury, MA
Duration: 12+ Months With Possible Extension
Pay Range :$30 to $47/Hr. on W2
Job Description:
- This position is responsible for performing change controls, creating and updating quality management procedures, managing records, and performing internal audits in compliance with the Quality Management System.
- Assists with the analysis of data for quality management system metrics, regulatory activities and supports quality management system projects and tasks.
Description of Work:
- Generates, reviews, and maintains division level quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiates Change Controls and Document Change Requests to update procedures and processes.
- Collaborates with manufacturing and distribution sites to assess the impact of changes to site level processes.
- Assists with monitoring and assessing quality system metrics to ensure maintained compliance.
- Acts as a lead auditor for division internal audit program.
- Assists with completing quality projects and uses root cause analysis to assist in the completion of CAPAs.
- Supports or leads continuous improvement initiatives for quality management system processes.
- Assists with regulatory activities.
Minimum Qualifications:
- Bachelor’s Degree, 3+ years of work equivalent experience (work in a manufacturing environment is preferred).
- Master’s Degree, 1+ years of work equivalent experience (work in a manufacturing environment is preferred).
Skills/Experience:
- Previous experience using ETQ software preferred
- Proficiency in Microsoft office
- ISO 13485 and 21 CFR 820 Quality Management Systems knowledge
- Internal auditor experience and/or training
- Must be detail oriented and accurate
- Ability to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
- Ability to work across matrix organizations and external consultants.
- Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
Source : Integrated Resources, Inc