Job Description

Job Description

Job Description

Job Overview
We are seeking a dedicated and detail-oriented Quality Assurance Engineer to join our dynamic team. The Quality Assurance / Regulatory Affairs Engineer I will be responsible to create and maintain Quality Management System documentation and regulatory submissions. The QA/RA Engineer I will also support Quality Management in regulatory and customer audits, investigating customer complaints and corrective actions, processing supplier changes, and maintaining the Standards Library.

Essential Duties and Responsibilities:

The QA/RA Engineer I performs the following duties:

• Reads and understands all Quality Management System (QMS) procedures related to the position / function within the organization.
• Updates and maintains QMS documentation.
• Supports the construction and maintenance of product technical files and regulatory submissions.
• Supports and coordinates Clinical Evaluation Reports (CER).
• Supports and coordinates Post Market Surveillance (PMS) activities.
• Assists in writing technical opinions / rationales.
• Assists in the registration of products in foreign countries.
• Supports regulatory and customer audits of the QMS and Technical Files.
• Support in the evaluation of product complaints and initiate corrective actions as needed to improve product quality and work with customers, internal manufacturing, and external suppliers in resolving quality issues.
• Evaluates and reviews new or revised standards to identify potential gaps which could result in non-compliance.
• Completes special projects as assigned.

Supervisory Responsibilities

• This position has no supervisory responsibilities.

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
• Minimum of 1 years’ experience working in a Medical Device environment preferably in a Manufacturing, Quality Engineering, Quality Assurance or Document Control role

Technical Skills

• Working knowledge of processes and their interactions.
• Working knowledge of the current ISO 13485 standard
• Working knowledge of the current FDA QSR requirements
• Working knowledge of the current EU Medical Device Requirements (MDR).

Language Skills

• Ability to read and understand regulatory standards
• Strong writing skills, spelling, punctuation, grammar, etc.
• 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 mathematical and statistical concepts.

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.
• Attention to detail.

Computer Skills

• Good working knowledge of Microsoft Office, Adobe Acrobat, Minitab and certain elements within the PMG QA Database,
• Able to use the Internet to research technical literature, clinical trials, the FDA and similar regulatory websites.

Company Description

Primo 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 Description

Primo Medical Group, Inc. is a leader in the development of medical devices and precision machined components with currently four locations. \r\n\r\nPrimo 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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