Quality Assurance (QA) Specialist, Fort Collins, CO

Job Functions and Responsibilities

1. Quality Management System Documentation Development and update quality management system documentation and records keeping to ensure compliance with the Quality Manual.

Supports development of quality procedures such as SOP’s and Work Instructions when required. Aid Quality Assurance / Regulatory Manager in the transition to new standards as they develop.

Establishes and maintains records as evidence of compliance to quality management system requirements. (Essential)

2. Change Management Administrates the change management system. Ensures validation of changes and associated risk analysis are completed and documentation. (Essential)

3. Corrective and Preventive Action (CAPA) Takes an active role in facilitating the Corrective Action process. Takes initiative in problem-solving for continuous quality improvement relative to raw materials, product testing and product performance.

Communicates continuous improvement suggestions to management regarding quality issues and concerns of customers. Submits quarterly CAPS report to management. (Essential)

4. Process Control Plans, conducts and oversees test and inspections of materials and products (ex : sampling) to ensure quality is maintained. (Essential)

5. Quality System Auditing Leads internal audits, documents findings and works with departments to provide effective corrective action.

Participates in external audits. (Essential)

6. Technical Writing Helps develop technical documentation quality procedures, work instructions, calibration procedures, quality plans and quality related forms. (Essential)

7. Performs other functions or duties as assigned. (Supplemental)

Job Requirements :

Knowledge, Skills, Abilities, & Worker Characteristics

• Demonstrated knowledge of ISO 13485 and Quality Management Systems (QMS).
• Ability to run statistical analysis and prepare charts and graphs (using statistical and graphics packages), sampling methods, metrology and calibration programs, ERP systems and the internet.
• Able to read and understand manufacturing orders and complex work instructions, and material handling documents.
• Experience in handling the CAPA (Corrective Action and Prevention Action)
• Experience in providing training.
• Experience in developing quality documents.
• Degree in technical or engineering field is desired, or 3 years of equivalent experience in Quality Assurance.
• Quality Certified and / or Certified ISO auditor preferred (optional).

Summary Education & Experience Required

• Degree in technical or engineering field is desired, or 3 years of equivalent experience in Quality Assurance.
• Quality Certified and / or Certified ISO auditor preferred.
• Advanced skills in Excel and MS Word desired.
• Must possess a thorough knowledge of quality assurance principles

Working Conditions

Typical laboratory setting with daily exposure to the potential hazards of working with chemicals and chemical by-products, especially the daily use of silica and nuisance dust-containing products.

Daily exposure to the noise levels and potential dangers of tools and equipment in a typical machine shop environment.

Travel

Position may be based in Louisville, Kentucky or Fort Collins, Colorado. If based out of Colorado, candidate must be able to initially train in Louisville KY for up to three months.

Education Requirements (Any)

Techincal Degree or Equivalent

Additional Information / Benefits

Benefits Include : Medical, Dental and Vision Insurance, Life Insurance, 401k Plan, Paid Vacation, Paid Sick Days, Paid Holidays, Short Term Disability, Long Term Disability