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Senior Quality Engineer- Design Assurance

Shelton, Connecticut | Boston, Massachusetts | Hopkinton, Massachusetts | New York, New York

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Responsibilities

Location Shelton, ConnecticutUS Job ID JR-017886

PerkinElmer Inc. is looking to hire a Senior R&D Quality Engineer to join its Quality Regulatory and Medical team. The candidate will be a part of a team that provides focused quality engineering support for new product development, design changes and sustaining engineering. They will help develop, establish and maintain quality engineering methodologies, systems, and practices which meet PKI, customer, and regulatory requirements. They should be knowledgeable in design and process control for product development.

Responsibilities:

  • Acts as the quality representative on design core teams to support the design control process, including new product design, specification development and preparation, verification and validation, design changes, risk management, report preparation, technical documentation, and commercialization of products.

  • Assesses written product and project documentation for compliance to applicable standards, regulations, internal requirements, and project goals

  • Assists with the assembly, control, and maintenance of product design history files, risk management files, and technical documentation

  • Analyzes, draws conclusions from, and reviews test results to evaluate conformance to specifications and assess risk.

  • Supports and participates in sustaining engineering projects, including quality initiatives and post market design changes and improvements.

  • Participates in the engineering change process for requests involving product or process changes. 

  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to design, material, and/or process.

  • Acts as an effective team member in supporting quality disciplines, decisions, and practices.

Basic Qualifications:

  • Bachelor of Science Degree in Engineering, Medical Technology, or related field

  •  5-8 years of experience working in R&D, Quality, or Manufacturing of regulated products, such as medical devices and/or in vitro diagnostic devices

Preferred Qualifications:

  • Previous experience with 21CFR820, ISO13485, and ISO14971

  • Working knowledge of Medical Device regulations

  • Working knowledge of verification and validation requirements for regulated products

  • General knowledge and application of technical and business concepts, procedures and practices

  • Strong problem-solving skills and attention to detail

  • Effective communication and technical writing skills

  • Able to collaborate effectively in a team environment, and to lead critical project tasks to completion and/or resolution

  • Certification(s) and/or coursework relevant to Quality or Design Assurance

  • Previous experience with 21CFR820, ISO13485, and ISO14971

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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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