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Randstad Quality Engineer in boston, Massachusetts

Quality Engineer

job details:

  • location:Boston, MA (remote)

  • salary:$55 - $62.25 per hour

  • date posted:Monday, May 3, 2021

  • job type:Contract

  • industry:Manufacturing

  • reference:837022

job description

Quality Engineer

job summary:

Come join our team where we are innovators, leaders, and collaborators. And at the heart of everything we do is an intense desire to pursue the toughest challenges and truly change the world for people living with rare and devastating diseases.We are incredibly proud that our work has been recognized globally through some of the industry's highest honor.

location: BOSTON, Massachusetts

job type: Contract

salary: $55.00 - 62.25 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities:

Position Summary & Scope

This position will serve the role of Quality Engineer for combination products within the Global Operations Quality function of the company. The Quality Engineer, Investigations will focus primarily on the customer complaints reported for the company's combination products. The candidate will support technical investigational review activities for device and combination products in support of our organization's Global Complaint Handling process.

Principal Responsibilities

  • Ensure timely entry, processing, and closure of quality records in compliance with the organization's Global Complaint Handling procedures.

  • Lead periodic reviews related to clinical and commercial device and combination product investigation outcomes.

  • Liaise with internal and external parties related to device related investigation outcomes and root cause assessments.

  • Partner with risk management to ensure Post Market Surveillance requirements are met.

  • Perform data analytics on the company's global complaint data in order to support trend analysis and determine further actions or ad-hoc risk assessments to be performed.

  • Communicate effectively, both verbally and in writing, internally across departments and with external partners.

  • Comply with the company's quality assurance requirements as well as applicable regulatory requirements.

  • Support audits and inspections, as appropriate.

  • Other duties as assigned.

Qualifications

  • Minimum of 3 years of experience in medical devices or related industry with a concentration in Quality Systems, investigation techniques, root cause analysis and risk assessment

  • Previous experience in handling and processing medical device complaints required

  • Previous working experience in a medical device manufacturing environment preferred

  • Knowledge of the regulatory and compliance requirements of device design controls and combination products ( i.e. FDA QSR 21 CFR Part 4 and 820 / ISO13485 quality system requirements).

Education

Bachelor's Degree in Engineering (Biomedical, Mechanical, or Electrical Engineering).

Competencies

  • A strong customer focus and ability to prioritize and adapt to business needs are required

  • Demonstrated project management skills, experience leading and participating on cross-functional teams, problem solving and decision making

  • strong business partner with a focus on collaborating and delivering results.

  • strong leadership, negotiation, collaboration and influence skills in a matrix organization

  • Knowledge of applicable international GXP regulations and standards

  • strong ability to analyze systems, data

  • Extensive knowledge of investigation techniques and tools

  • Extensive knowledge of risk assessment strategies and tools

  • Capable of identifying and mitigating risks

  • Excellent written and verbal communication skills

  • Experience with high performance teams, cross functional projects

qualifications:

  • Experience level: Experienced

  • Minimum 3 years of experience

  • Education: Bachelors (required)

skills:

  • Quality

  • Quality

  • trackwise

  • gxp

  • medical devices

  • compliance

  • audit

  • risk assessments

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.

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