Randstad Quality Engineer in boston, Massachusetts
location:Boston, MA (remote)
salary:$55 - $62.25 per hour
date posted:Monday, May 3, 2021
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
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.
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.
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).
Bachelor's Degree in Engineering (Biomedical, Mechanical, or Electrical Engineering).
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
Experience level: Experienced
Minimum 3 years of experience
Education: Bachelors (required)
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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