Senior Quality Engineer-Medical Device

We are currently recruiting for a Senior Quality Engineer, but we are looking for more than an impressive skill set.

We are looking for the type of person who respects others for their knowledge, skills, and experience as individuals and as team members.

If you are the type of person who has high integrity and would thrive in an inclusive environment of camaraderie and friendship with your fellow teammates, we're pretty confident you'll love it here

Responsibilities:


* Plan, devise and implement Quality Assurance standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned complex project or area to assure the highest quality levels and cost ‑ effective compliance with contractual and HIARC requirements.

Develop test techniques and procedures as required.


* Assist in planning, devising and implementing Quality Assurance standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned project or area to assure the highest quality levels and cost ‑ effective compliance with contractual and Company requirements.


* Apply basic engineering and scientific principles and techniques to assist in the development and establishment of quality assurance programs which provide and maintain the highest quality levels for an assigned project, product, or area.


* Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of assigned products or production equipment.


* Conduct experiments and audits to evaluate operating characteristics of products or processes.

Evaluate data from experiments and prepare reports and summaries outlining results and recommend revisions or modifications to the product or process to maintain or improve product quality.


* Support customer and regulatory audits and assist in completing corrective actions to resolve any findings from audits


* Assist in evaluating producibility and reliability of the finished product, ensuring that all established standards and regulations are met.

Assist in determining equipment to be used to maximize manufacturing effectiveness and minimize cost.


* Assist in complete failure analysis investigations to determine the root cause and take appropriate corrective action to revise design, methods and inspection/test instructions to prevent failure recurrence.


* Evaluate and monitor quality of vendor services and goods and recommend selection of optimum vendors.


* Serve as member of Material Review and Configuration Control Boards.


* Support the manufacturing process in resolving design problems, assist in the transition of products from development into production.


* Review and assess Engineering Change Orders (ECOs) for design and process changes to ensure compliance with quality and regulatory require...