QA Engineer II

View the video below on how you can make a difference by joining Breg:

Are you looking for an exciting opportunity?

We currently have a full-time opening for a Quality Engineer II. If you are looking for a fast-paced environment where you can make a difference every day, then this is the opportunity for you!

The right person to join our team is

Demonstrates ownership and accountability; demonstrates the ability to: plan, execute, control and deliver; communicate effectively both written and verbal; lead and influence others effectively.

This position is responsible for....

The Quality Engineer II is responsible for providing Quality Engineering support for new products and product improvements, from concept through design and validation, and into production through stable operations. S/he will also support manufacturing in resolving issues for both new and established products.

Your day will be very busy... you will:

• Participates in cross functional project teams to support new product development and quality improvements.

• Leads investigation, corrective/preventive action and implementation of quality improvements.

• Manages the Supplier Quality program; participates in selection and qualification of new suppliers, manages the supplier audit program and supplier corrective actions.

• Manages supplier quality controls and implements supplier improvement strategies.

• Performs technical reviews and/or develops keys documents including quality and reliability plans, FMEA, product and process validation plans and reports, and sample size justification.

• Provides Quality Engineering project support throughout the product development lifecycle, including but not limited to:
  • Assisting with the development of product requirements and specifications
  • Ensuring project compliance to internal and external standards
  • Coordinating risk analysis activities
  • Creating and managing the Quality Engineering deliverables
  • Owning and driving Corrective and Preventative actions
  • Generating/coordinating verification and validation test activities, acceptance criteria and sampling sizes

• Develops and implements robust measurement systems through application of tools such as Measurement System Analysis (MSA).

• Serves as the Quality focal point for the project team and the customer on all items related to safety and regulatory compliance, as well as compliance with all Breg procedures.

What your background will be:

• Bachelor's degree in a scientific discipline with 2+ year's related medical device experience or Master's degree in a scientific discipline with 2+ years related experience. An equivalent combination of education and experience also accepted.
• ASQ (CQE, CRE, CQA, etc.) certifications desired.
• Experience with electromechanical devices preferred.
• Must have proven experience with FDA audits or regulated body audits such as ISO.
• Must have risk management experience including generating risk analysis and applying the concepts and principles of ISO 14971.
• Lean Manufacturing and Project Management experience preferred.
• Must be proficient in validation and evaluation methods.

What we can offer you

Our insurance benefits are effective the 1st of the month after your hire date.

• Medical /Dental /Vision plans
• PTO (paid time off)
• Holiday Pay
• Life Insurance / STD / LTD

Salary/Pay Range

$83,100 - $90,500

For six consecutive years Breg has been awarded The National Business Research Institute (NBRI) Circle of Excellence Award for employee engagement.

If you meet the requirements above and would like to apply for this position, please visit our website at www.breg.com and click on the 'Careers' section.

Breg is an Equal Employment Opportunity Employer and dedicated to a diverse work force and Drug Free work environment. EOE/Minorities/Females/Vet/Disabled are encouraged to apply.