SMC Integration Solutions

SMC Integration Solutions is seeking a Quality Systems Specialist for our facility in Nicholasville, KY. The Quality Systems Specialist provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of service conform to established internal and external standards and guidelines. ISO9001, ISO13485, FDA 21 CFR, Risk Management, and Validations processes is vital for this role.

Essential Functions:

  • Ensures all applicable internal/external quality and regulatory requirements are fulfilled on an ongoing basis including but not limited to elements of 21 CFR 820, FDA Quality System Regulation, and ISO 9001/13485.
  • Assures all routine inspection and documentation requirements are fulfilled.
  • Maintain document/change control.
  • Share in customer complaint responsibilities.
  • Maintain an IPC training program (internal/external)
  • Perform required classroom training for procedures and processes within the QMS.
  • Collects and analyzes system data/information, prepares reports and works with executive management and other functional groups to define and implement quality plans.
  • Lead the Audit Team in developing an annual internal audit schedule and leading the team to perform internal audits per the ISO9001/ISO13485/FDA guidelines and develop audit reports.
  • Lead Safety Team to perform internal safety audits for basic OSHA safety.
  • Maintain the corrective action system by assisting with corrective and preventative action process, including assigning, failure investigation and root cause analysis.
  • Maintain the Calibration/Preventive Maintenance System.
  • Maintain and monitor the Non-Conformance System
  • Maintain a Medical Device File for all Medical Device Products.

Competencies:

  • Must be able to perform solo internal audits per standards/guidelines.
  • Excellent decision making and problem-solving skills.
  • Strong organizational, documentation, and record keeping skills.
  • Ability to multi-task, set priorities and meet deadlines.
  • Strong communication skills.
  • Teamwork is a condition of employment.

Required Education and Experience:

  • High School Diploma/GED
  • 5-10 years of experience in a QA department in a related industry required
  • Proficiency in use of Excel, Word, and other PC applications

Preferred Education and Experience:

  • BA/BS (or a BSN) in a business/technical field preferred.
  • ISO Internal Auditor Certificate(s)
  • Strong Project Management Skills
  • Excellent communication skills both oral and written – including presentation skills
  • Good teamwork skills, as well as the ability to work independently
  • Strong problem solving and project planning skills
  • Medical Device Experience

Benefits:

  • 401(k) and 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Apply Now

SMC is currently taking applications. Please download the employment application and return it to our facility, email it to our HR department (hr@smckyems.com) or stop by and fill one out.

If you require an accommodation or additional assistance in completing the application, please contact our HR department at 859-885-9658 Ext. 283 or Ext. 228, or you can reach us via our email address previously listed.

Application for Employment
Submit Application on Indeed

About SMC Integration Solutions

SMC has been a successful electronics manufacturing company for decades, providing full-service electronics manufacturing services and systems integration. We are customer-focused and partner with companies that need the manufacturing services support we provide. Our commitment to Principles, People, Process, and Performance (the 4 P’s) gives us the confidence to offer direct fulfillment to the end customer. SMC believes in a genuine, integrated partnership.

We have become a thriving corporation by recruiting the “right” employees, choosing the best equipment, installing all the necessary engineering services, and utilizing our business principles.

EEO Statement:

It is our policy to provide equal employment opportunity to all individuals. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful. We are strongly committed to this policy and believe in the concept and spirit of the law.