Job Details

ID #12217025
State Massachusetts
City Danvers
Job type Contract
Salary USD $60.96 - $73.16 per hour 60.96 - 73.16 per hour
Source Real Staffing
Showed 2021-04-14
Date 2021-04-14
Deadline 2021-06-13
Category Et cetera
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Sr Manufacturing Engineer- Medical Device- Onsite Position

Massachusetts, Danvers, 01923 Danvers USA

Vacancy expired!

Sr Manufacturing Engineer - Medical Device

Location: Danvers, MA Onsite position

Duration: Contract through 4/29/2022

Benefits: Health, Dental, Vision Benefits & 401K Enrollment

Primary responsibilities include:

  • Capable of authoring and executing process validations (IQ, OQ, PQ) in accordance with QSR, FDA and international procedures including data analysis through statistical methods.
  • Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks including PFMECA updates and escalation of Design Document changes as needed.
  • Skillfully utilizes problem solving tools to analyze and identify root cause and to implement corrective actions.
  • Makes decisions and proposes solutions based on calculated risks.
  • Originate and complete changes and change orders in compliance with Quality System Regulation (QSR 21 CFR 820), ISO 13485:2016, Danvers Quality Business System, and Corporate Policies.

Seeking:

  • Bachelor's degree in engineering discipline
  • 5+ years Manufacturing Engineering experience in a GMP environment or highly regulated industry with a BS degree. 2+ years with a Master's degree
  • 5+ years of Manufacturing Engineering experience in a QSR (GMP) medical device environment
  • Demonstrated working knowledge of process validation, statistical methods, risk management
  • Knowledge of EU MDR Requirements

W2 Employment Opportunity- Unable to offer sponsorship

Sthree US is acting as an Employment Business in relation to this vacancy.

Vacancy expired!

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