Associate Quality Engineer

Job Description

QUALITY ENGINEER - BE A PART OF AN AMAZING TEAM!

Primo Medical Group,Inc. is searching for an Associate Quality Engineer to join our team! We are a leader in the development of medical devices and precision machined components. There are currently four locations, 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.

Associate Quality Engineer Essential Duties and Responsibilities:

• 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.
  
  

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.
  
  

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.
  
  

Quality Engineer Requirements:

• Bachelors Degree in a technical discipline.
• Minimum one (1) year experience in Quality Engineering/Product Development.
• Working knowledge of FDA 21CFR820 Quality System Regulations (QSR), ISO13485 Quality Management System and 93/42/EEC as amended by 2007/47/EC (MDD).
• Ability to write reports, evaluations and business correspondence.
• Ability to effectively present information and respond to questions from managers, employees, customers and suppliers.
• Ability to calculate and analyze statistical concepts such as D.O.E. process capabilities, T-Tests and Normal Distribution.
• Ability to solve practical problems using a common sense approach.
• Must have good working knowledge of Microsoft Office, Adobe Acrobat and the QA Database Mini Tab or other similar statistical software programs.
  
  

We Offer:

• Completive compensation
• Excellent benefits
• Professional Growth Assistance
  
  

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 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.

English Language Skills Are Required For This Position.

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. English language skills are required for this position.