Skip to main content

This job has expired

Sr. Quality Engineer – Product Development

Employer
Perkin Elmer
Location
Hopkinton MA US
Closing date
Mar 28, 2017
Summary: An experienced engineering professional who works well in a cross-functional team environment. The individual will lead our efforts to attain and maintain Design Control compliance, as well as ensuring that we comply with applicable regulatory and statutory requirements. They are responsible for providing quality engineering support for medical device products. They support design changes, perform quality analysis and collaborate with internal and external team members to ensure product specifications are satisfied. They are involved in the entire development process to ensure quality and compliance to support the development and design of the final medical device. Must be able to work independently to resolve regulatory compliance and quality program related issues in a creative, high quality, timely and cost-effective manner. Core values must include commitment to customer excellence with demonstrated ethics and integrity. Duties and Responsibilities:
  • Provides quality system methodology guidance, support and review for medical device products throughout the design, development and change control processes.
  • Actively participates on cross-functional design teams reviewing design documentation for quality characteristics including product requirements, risk management, verification/validation, manufacturability, serviceability and packaging.
  • Ensures projects are developed and released that satisfy customer expectations, regulatory requirements including, but not limited to, 21-CFR-820, ISO 13485, ISO 14971 and FDA Software Guidance documents.
  • Reviews, approves and provides input as necessary to assist R&D in the creation of verification and validation plans, protocols and reports.
  • Participates in product risk assessment efforts within product teams and updates to existing product lines.
  • Provides support to facilitate resolution of product complaints and/or safety issues.
  • Participates in problem solving efforts to identify and resolve quality issues to ensure production of safe and effective medical devices. Works with the team to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives
  • Conducts investigations to identify root cause of problems and implements effective corrective actions. Participates in internal audits and continuous improvement projects.
  • Develops quality system procedures through cross-functional teams where needed.
  • Supports insourcing projects as well as Continuous Improvement and LEAN projects as Quality Representative to ensure projects meet internal Quality requirements.

Provides project direction and leadership in general quality program issues to support Quality Department effectiveness in support of quality initiatives. Recommends and implements enhancements to the Quality System that result in improved performance, increased customer satisfaction, and simplification of processes to reduce costs.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert