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Quality Manager
Ref No.: 17-02957
Location: Springville, Utah
Job Title: Quality Manager
Location: Springville, UT
Duration: Contract-to-hire, long-term
Salary: $38-$43/hr DOE

Job Responsibilities:
The position is responsible for overseeing the Quality Control Department, Quality functions of Utah Manufacturing and Quality Management Systems ISO 13485 compliance in Utah and Costa Rica.
This position defines the requirements and leads employees on the processes used to develop, establish, and maintain quality compliance programs, policies, procedures, and controls to ensure that all products conform to cGMPs, established standards, agency regulations, guidelines, and industry compliance trends.

Quality Systems (QMS):
Oversees and is directly responsible for the Quality Management System Compliance Program in Utah and Costa Rica with respect to 21 CFR part 820, ISO 13485 and ISO 9001
Works with the Global Director of Quality Assurance and Regulatory Affairs in planning, developing, improving and running the Global QMS and Corporate level QMS procedure adaptation and use
Regulatory Compliance:
Interprets and provides guidance regarding regulatory agency regulations, guidelines, and internal requirements to ensure site compliance.
Responsible for Regulatory Agency (FDA, MDD, CMDR, etc.) contact, audits, and correspondence.
Responsbile for Medical Device Reporting as defined in 21 CFR part 803, and directly handling reportable events and Customer Complaints internally within the Customer Feedback Process
Responsible for FDA Registration and Listing Activities as defined in 21 CFR Part 807
Oversee ISO class 8 clean room compliance and monitoring
Oversees the UT Manufacturing Quality Control department and activities
Responsible for Quality Systems and cGMP Training oversight
Oversees Quality Department Requirements of QOP-0004 Competency, Awareness and Training Procedure as assigned by the Process Owner and the Global Director of QA/RA
Trains and develops indirect reports in processes and functions applicable to the nature of the indirect report relationship, supporting and coordinating development activities with the solid line supervisor.

Job Requirements:
Bachelor's Degree in a relevant field
2+ Years in a managerial role supervising employees in a quality environment
Expert knowledge of ISO 13485 or 9001
ISO 13485 or 9001 Lead Auditor Certification preferred

Preferred/specialized training in the following:
Medical Device Manufacturing
FDA Regulation, specifically 21 CFR Part 820
Regulatory Communications
Document/Record Control Systems
Clean Rooms
Root Cause Analysis
CAPA