Quality Control Manager - Woodstock, CT
Directly supervises 4 to 8 employees in the Quality Control department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485;2003 standard is essential.
2. MT&E control experience. Calibration (ISO 17025). Gagetrak software experience a plus
3. Knowledge and experience in risk management, tolerance studies, product reliability and safety assessments, Design FMEA, gage R&R, SPC, ISO 13485, FDA QSR, design verification, process validation, documentation control, reliability testing and developing sampling plans for verification/validation. PPPAP and MPAP documentation completion. 4. IQ/OQ/PQ V & V process and reporting documentation.
5. Quality Assurance experience with Medical devices is essential.
6. Knowledge of statistical and engineering principles is essential. Process capability studies (CpK, CP, CR). Data Regression Analysis, Pareto Analysis.
7. Product regulatory experience: RoHS, REACH, UL, CE.
8. Experience with FDA inspection and ISO 13485 audits and CE marking is a plus. Experience with ERP systems (Syteline), automated data collection systems, and product data management systems is a plus.
9. Project management skills are vital.
10. Must be able to effectively communicate and interact with all departments within the company.
Keywords: FDA, Medical device, quality, manager
Full Time, Career Position
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