Quality Engineer

4 weeks ago

Stoughton, United States Primo Medical Group Full time

Job DescriptionJob Description

QUALITY ENGINEER - BE A PART OF AN AMAZING TEAM

Primo Medical Group ,Inc. is searching for an Quality Engineer to join our team We are a leader in the development of medical devices and precision machined components. Primo is a dynamic, innovative company offering competitive salary, excellent benefits and has a strong focus on the training and professional advancement of its employees.

The Quality Engineer will be responsible to represent Quality Assurance on Design and Development Teams and assure that new product designs and the processes for manufacturing them meet all internal and regulatory requirements with respect to product quality, safety and efficacy. The QE performs the following duties:

Essential Duties and Responsibilities:

  • Reads and understands all Quality Management System (QMS) procedures related to the position / function within the organization.

  • Ensures compliance to applicable regulatory standards, customer requirements and internal procedures related to Design and Development activities.

  • Supports Design and Development activities for new product development, including regulatory submissions.

  • Leads and documents Design and Process Risk Management activities.

  • Leads and documents Design Verification and Validation activities

  • Provides recommendations and opinions for Design / Development Input, Planning and Transfer activities.

  • Develop, document and validate inspection and test methods to support in-process and final inspection activities.

  • Support Product / Process Transfers from one facility to another.

  • Evaluate product complaints and initiate corrective actions as needed to improve product quality and work with internal manufacturing and external suppliers in resolving quality issues.

  • Provide project direction, coaching and mentoring for less senior Engineers and technical team members as appropriate.

Supervisory Responsibilities

  • There are no supervisory responsibilities for this position

Qualifications

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

  • Bachelor’s degree in a technical discipline and a year minimum experience in a Quality Engineering / Product Development environment or equivalent combination of education and experience. Working knowledge of FDA 21CFR820 Quality System Regulations (QSR), ISO 13485 or ISO 9001 Quality Management Systems and 93/42/EEC as amended by 2007/47/EC (MDD).

Language Skills

  • Ability to write reports, evaluations and business correspondence.

  • Ability to effectively present information and respond to questions from managers, employees, customers and suppliers.

Mathematical Skills

  • Ability to apply intermediate math concepts. Ability to calculate and analyze statistical concepts such as D.O.E., Process Capability, T-Tests and Normality of Distribution

  • Reasoning Ability

  • Ability to solve practical problems using a common sense approach.

  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

  • High attention to detail.

Computer Skills

Individual should have a good working knowledge of the elements within Microsoft Office, Adobe Acrobat and the QA Database. MiniTab or other statistical software experience is also required.

Primo Medical Group, Inc. is an Equal Opportunity Employer and ay offer reasonable accommodation to enable individuals with disabilities to perform the essential functions of the position.

Company DescriptionPrimo Medical Group, Inc. is a leader in the development of medical devices and precision machined components with currently four locations.

Primo Medical Group, Inc. is an Equal Opportunity Employer and may offer reasonable accommodation to enable individuals with disabilities to perform the essential functions of the position.Company DescriptionPrimo Medical Group, Inc. is a leader in the development of medical devices and precision machined components with currently four locations. \r
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Primo Medical Group, Inc. is an Equal Opportunity Employer and may offer reasonable accommodation to enable individuals with disabilities to perform the essential functions of the position.

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