Sr. Quality Technician - Medical Device Manufacturing

Summary

The Quality Technician will work with Operations to ensure product is manufactured and compliant to specifications, relevant industry standards, and regulatory requirement. They will perform routine checks during manufacturing as well as support lot sampling of product. In addition, they will support testing and measurements associated with validation and verification testing of product.


Responsibilities

  • Assist in external audits of critical suppliers; assist in internal audits and third-party audits of Corvida, including actions tied to continuous improvement of the quality system

  • Support quality functions tied to on boarding of new suppliers

  • Perform in-process checks and lot sampling inspection of manufactured product, including, but not limited to:

  • Injection molded components

  • Supplied components

  • Sub-assemblies

  • Finished good assemblies

  • Utilize measurement tools and equipment to inspect and test product, including:

  • Hand inspection tools such as calipers, micrometers, gage pins, etc.

  • Automated inspection systems, including CMM and vision systems

  • Automated and manual tensile testers and force gages

  • Leak testers, including pressure testers and vacuum decay testers

  • Other custom lab equipment

  • Follow existing test and inspection methods as well as develop new inspection and test methods

  • Support of complaint handling process

  • Manage document control system

  • Support inbound/outbound product movement tied to product acceptance and release

Authority

The Quality Technician is empowered with the authority to perform his/her assigned responsibilities and tasks as outlined in this job description and where documented in the Quality Management System policies and procedures.


Required Qualifications and Skills

- Experience in medical device manufacturing

- Experience using manual and automated test and inspection equipment

- Familiar with ISO 13485 compliant quality systems, current Good Manufacturing Practices (cGMP), and 21 CF Part 820; preferable to be familiar with MDSAP

- Preferred experience in statistical process control (SPC) and AQL lot sampling plans

- General computer experience, including Word, Excel, ERP/MRP systems, etc.

- Attention to detail and accustomed to producing high accurate work

- Ability to work in a very fast paced environment with minimal supervision

· High school education or equivalent, prefer two year associates degree

· Minimum 5 years’ experience in a similar role within Manufacturing and/or Quality


Training Requirements

Training requirements are defined in the Competency, Awareness and Training Standard Operating Procedure (SOP-112).


Send resume to sharon@mccordexecutivesearch.com

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