Quality Engineer

Job Title: Quality Engineer

Salary Range: $70,000 – $80,000

Full benefits package of vacation, short and long term disability, long term care, company paid life insurance, and medical, dental, and vision benefits.

Benefits: Medical Insurance, Life Insurance, Dental Insurance, Vision Insurance, Paid Vacation, Paid Sick Days, Paid Holidays, Short Term Disability, Long Term Disability, 401K/403b Plan

Job Skills / Requirements

The Quality Engineer is responsible for all aspects of quality assurance in the design, production and technical documentation of medical device products. Is responsible to design and implement tests that monitor the quality of the medical device in each stage of the production process.  Ensures medical device documentation is maintained in accordance with cGMP, ISO 13485, MDR and MDSAP.

This position supports Product Development teams to ensure compliance of new or modified products and processes to the appropriate quality standards. Prepares and submits 510(k) notifications, and technical files. Is also responsible for achieving and maintaining the CE Mark for medical.

Job Functions and Responsibilities 

1.

Works with design teams to ensure Design & Development (D&D) activities produce a product that is safe and meets customer needs. Create D&D documentation in accordance with applicable standards.  Essential                                                                                              

20%

2.

Helps design and validate production process for the manufacture of medical and non-medical products and monitors process performance.                 Essential

15%

3.

Coordinate 510(k) and CE Mark documentation, testing and submittal.              Essential

10%

4.

Ensures the device technical documentation is in compliance with national standards.       Essential

10%

5.

Coordinates external quality system audits by outside parties such as FDA, ISO, customer inspectors/auditors.   Essential                                       

10%

6.

Conducts risk and capability analysis to evaluate and validate product design and process capability and ensures design master/history files contain appropriate information.                            Essential

 

10%

7.

Participate on new product development teams to ensure the appropriate regulatory requirements are met for new/improved products.                                   Essential

10%

8. 

Helps develop the quality plan for incoming and outsourced materials and products.                                                              Essential

5%

9. 

Assists the quality team to conduct root cause analysis, corrective action planning, follow-up on actions and timely closure of CAPS’s.   Essential

5%

 

10. 

Conducts data analysis and creates trend charts using statistical methods.                         Essential

5%

11. 

Performs other functions or duties as assigned.

 

Job Requirements

Knowledge, Skills, Abilities, & Worker Characteristics     

  1. Must possess in depth knowledge and experience with ISO 13485 QMS standard
  2. Demonstrated ability to create statistically valid protocols to validate product design and process capability
  3. Demonstrated ability to critically think through, and apply logic to, complex problems
  4. Ability to effectively interpret, communicate and assimilate regulatory standards and specifications to a variety of audiences
  5. Must be able to effectively communicate and work productively with other departments and team members
  6. Must be comfortable receiving direction verbally as well as through written communication
  7. Some experience with Data Analysis tools and reporting complex data visually
  8. Must be able to work independently with minimal supervision
  9. Expert proficiency with MS Office Suite (specifically Excel and Word)

Summary Education & Experience Required 

  1. Bachelor’s degree in Engineering or another Technical or Scientific field is required
  2. 2+ years of experience in ISO 13485 QE role is required
  3. ASQ CQE certification is preferred
  4. Experience in a manufacturing environment is preferred

Working Conditions     

  1. Primarily office environment
  2. Must be able to access and traverse the entire manufacturing facility

Education Requirements (Any)

Bachelor’s degree in Engineering or another Technical or Scientific field

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