Senior manufacturing quality engineer

3 weeks ago

Agawam, United States Randstad Full time

job summary:
Our client is seeking a Sr Quality Engineer for their site in Agwam, MA. Incumbent will be focusing on quality management, documentation, audits, training, and compliance within the specified regulatory frameworks.

Required:

- Medical or Aerospace industry backround (ISO9001/AS9001)

- Inspection backround - hands on

HYBRID ROLE 2-3 ONSITE ONLY

CONTRACT ROLE- 4 MONTHS

APPLY

location: AGAWAM, Massachusetts
job type: Contract
salary: $100 - 120 per hour
work hours: 8am to 4pm
education: Bachelors

responsibilities:
Document Control:

  • Write and maintain ISO documentation for ISO 9001, ISO 13485, AS9100, and 21CFR part 820 compliance.

  • Process Document Change Orders (DCOs) and Engineering Change Notices (ECNs), ensuring proper revision control.

  • Update Bill of Materials (BOMs) as per ECNs and other inputs, and adjust quality planning accordingly.
Quality Planning and Audits:

  • Draft quality plans for new products and tests (IP Sheets).

  • Conduct internal audits, issue audit reports as Lead Auditor, and participate in third-party audits (customer, Notified Bodies, Regulatory Agencies).

  • Prepare for registrar audits and respond to customer quality system audits and surveys.
Records and Reviews:

  • Manage records retention for all products and maintain quality planning per part.

  • Prepare for semi-annual Management Reviews by coordinating preparations, providing supporting information, and writing meeting minutes.

  • Ensure compliance with records archives and obsolescence procedures.
Training and Customer Interaction:

  • Train staff as per the Training Master List for each new and revised document.

  • Prepare data and information for customer visits.
Supplier and Material Management:

  • Maintain raw material certifications and the Material Certification List.

  • Oversee the Supplier Surveillance program.
Corrective Actions and Cleanroom Testing:

  • Initiate corrective actions by drafting Corrective Action Requests (CAR), Preventive Action Requests (PAR), or Supplier Corrective Action Requests (SCAR).

  • Coordinate and maintain records for cleanroom testing, raw materials, and finished products as required.
Data Reporting and Calibration:

  • Prepare data and reports for senior management upon request.

  • Maintain the calibration system for equipment.
Protocol Creation and Execution:

  • Create Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and summary reports for customers.

  • Execute software validations.
Data Analysis and Supervision:

  • Use Minitab for populating data in part summary reports.

  • Supervise and support metrology and inspection resources.
#LI-LM1

qualifications:
  • Experience level: Experienced
  • Minimum 10 years of experience
  • Education: Bachelors

skills: Quality GD&T Manufacturing

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).

Applications accepted on ongoing basis until filled.

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