Position Overview

Provide integral support to the Quality and Manufacturing teams by ensuring incoming materials and finished products meet the established quality standards and world-wide regulatory requirements. Ability to handle the completion of a diverse set of projects and tasks required.

1. Ensure conformance to quality systems with respect to internal procedures, Quality System
Regulations (FDA CFR 21 820), ISO 13485-2003, Canadian Medical Device Requirements (CMDR) MDD 93/42
EEC and other applicable international standards and regulations

2. Perform complex mechanical, dimensional, and first article inspections of incoming components,
raw materials, in-process products/sub-assemblies and finished goods. Assist with monitoring the
SPC controls on the production floor

3. Manage the calibration program including scheduling, interfacing with outside services, review
of certifications, and maintenance of files. Provide review and approval of preventative
maintenance work orders

4. Responsible for related paper and electronic record keeping associated with all inspections,
including, but not limited to, part numbers, lot numbers, quantities, inspection results,
inspection dates

5. Provide a quality control review and release function for Device History Records and Sterile
load releases

6. Support Quality Engineering and Operations in the development and execution of internal test
methods, including use of various complex equipment and fixtures
7. Provide leadership and training to the QC and RI inspectors
8. Notify Management in the event of a nonconformance, noncompliance situation.
9. Perform additional responsibilities as assigned

    1. At least five (5) years of quality/manufacturing experience in the medical device industry
    2. Knowledge of basic measuring techniques including scales, rulers, and US and metric measurement
    3. Basic knowledge of QSR (CFR 21 820 and ISO 13485)
    4. Ability to follow company, quality and regulatory procedures and standards
    5. Strong written and verbal communication, organizational, and interpersonal skills
    6. Proficient with MS Windows, Word, Excel, Teams, and Outlook