Quality Manager

Position:

Quality Manager

 

Reports To:

Vice President, Operations

 

Department / Function: Quality

 

Span of Control:

The Quality Manager does not directly manage any staff but is responsible for overseeing and directing any staff with completion of quality related projects and tasks.

 

Major Job Function:

The Quality Manager represents the business quality function for the organization. Primary responsibility includes overall business quality and continuous improvement through ISO 9001 system implementation, maintenance and certification. The Quality Manager takes a proactive approach to prevention of issues by establishing standards, enforcing timelines, training staff, conducting audits and harmonizing processes to ensure efficient and effective workflow. Duties include data compilation and analysis, preparation of documents (word processing, spreadsheets, presentations), bookkeeping (item processing, reports, reconciliations), routine correspondence, coordination of shared resources, and meeting planning. Position requires excellent analytical skills, organization, flexibility, the ability to prioritize work, and experience in situations requiring accountability, confidentiality, and professionalism.

 

Classification:

Full Time, Non-Exempt.

 

Travel Requirement:

None.

 

Introductory Period:

90 days

 

Company Paid Pre-Employment Screening Required:

Drug Testing, Background Check

 

General Description:

The Quality Manager is a key position that coordinates the business processes to ensure integrity, compliance and continuous improvement. This position provides overall support of the quality management system through monitoring of results, management of non-conformities, oversight of corrective actions and implementation of opportunities for improvement. The Quality Manager must work through varies departments and teams to ensure consistent product and process results.

 

Mirachem is team-driven company. All employees are expected to assist in other areas of the company when the situation warrants, whether it relates to their primary function. This will include tasks such as office organization, work area clean up and maintenance, or other projects as requested by management.

 

Specific Duties:

• Functional Abilities
  • Expert proficiency with Microsoft Excel including pivot tables, lookups and graphing
  • Demonstrates advanced proficiency with word processing, presentations
  • Data compilation from various sources
  • Database design, creation, maintenance, use
  • Quality management, KPI monitoring and trend analysis
  • Awareness of regulatory requirements
  • Conforms to dress and appearance standards
  • Observes all safety requirements and conducts all duties in a safe and proper manner
• Documentation Control
  • Maintains, organizes and audits facility documents/records (SP 4.2 Control of Documents & Records)
  • Designs, implements and audits equipment IQ/OQ/PQ protocols (FC 7.6 Calibration)
  • Reviews product quality records prior to release (SP 4.2 Control of Documents & Records)
  • Coordinates routine review of data (experiments, trends, processes, projects) and assigns actions (PopRoq meetings)
  • Analyzes and documents performance of KPIs (SP 8.2.3 Monitor & Measurement of Process)
  • Implements Good Documentation Practices (GDP)
• Quality System
  • Documents quality events, formulates response, compiles data, monitors for recurrence and completes analysis
  • Organizes, plans and performs internal audits to evaluate the implemented management systems (SP 8.0 Measurement, Analysis & Improvement)
  • Monitors for compliance with customer requirements including effectiveness analysis (SP 7.2 Customer Requirements)
  • Organizes Management Review (QMR) meetings at planned intervals (SP 5.6 Management Review)
  • Strives to demonstrate continual improvement of the QMS System, products and services (SP 8.5.1 Continual Improvement)
• Quality Assurance
  • Guides staff for the detection and resolution of any issues dealing with quality through development and execution of Response Flow Checklists (RFC)
  • Ensures prevention of unacceptable material release (SP 8.3 Control of Nonconforming Product)
  • Identifies causes of quality problems, documents them, and devises solutions and corrections (SP 8.5.2 Nonconformity and Corrective Action)
  • Controls equipment calibration and maintenance pro