An Quality Engineer is needed for a manufacturing company considered one of the world's leading innovators in materials science in the Tewksbury, MA area. This position is responsible for maintaining and updating quality management system documentation, leading internal audits, managing change controls, supporting continuous improvement initiatives, and ensuring compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
location: Tewksbury, Massachusetts
job type: Contract
salary: $36.74 - 51.43 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Generate, review, and maintain division-level quality system documents (procedures, work instructions, job aids, certificates of conformance) in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiate Change Controls and Document Change Requests to update procedures and processes.
- Collaborate with manufacturing and distribution sites to assess the impact of changes to site-level processes.
- Monitor and assess quality system metrics to ensure continued compliance.
- Act as a lead auditor for the division's internal audit program.
- Assist with completing quality projects and use root cause analysis to resolve issues in CAPAs.
- Support or lead continuous improvement initiatives for quality management system processes.
- Assist with regulatory activities related to quality management systems.
- Experience using ETQ software (preferred).
- Proficiency in Microsoft Office.
- Knowledge of ISO 13485 and 21 CFR 820 Quality Management Systems.
- Internal auditor experience and/or training.
- Detail-oriented with a focus on accuracy.
- Ability to apply basic mathematical concepts (percentages, ratios, proportions).
- Ability to work across matrix organizations and with external consultants.
- Bachelor's Degree and 3+ years of equivalent work experience (preferably in manufacturing).
- Master's Degree and 1+ years of equivalent work experience (preferably in manufacturing).
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
