REPORTS TO: General Manager
LOCATION: Sanford, ME and/or surrounding areas
The QA Manager reports directly to the General Manager. The QA Manager directs the implementation, execution, and maintenance of a quality management system (QMS) in accordance with ISO 9001. As part of the direction of the QMS, the QA Manager ensures all responsible owners of company-wide quality policies, procedures, processes, programs, and practices conform or comply to internal and external customer defined standards and regulations.
DUTIES AND RESPONSIBILITIES
Direct supervision of assigned employees including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Adds value and encourages the development of Quality Assurance team members through certification training and relevant training exercises.
Manages employee training to educate newly hired employees in the use of the QMS documents and educates the company regarding changes to the QMS, via scheduled management review meetings.
Promote and support all company initiatives for safety and ensure compliance from assigned employees.
Serves as the Management Representative for ISO.
Works with internal subject matter experts to define critical to quality (CTQs) to document and assure conformance and or compliance to them.
Coordinates with Production, OPEX, and Engineering to ensure system, processes and procedures are created and implemented to meet customer expectations for product quality and delivery.
Supports new product and in-process testing, as well as final acceptance testing.
Cooperatively develops and implements testing schedules for standard and modified the companies products or customer inquiries.
Develops and initiates standards and methods for inspection, testing, and evaluation by identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, corrective actions, and verification procedures.
Supports the development of criteria, with support from OPEX and Engineering, for production test, test reports, and test inspection.
Supports activity for required testing to meet regulatory requirements, such as: UL, ETL, NSF, EN, IEST, CETA, FDA, RoHS, and GMP requirements
Supports on-site evaluations and audits of vendor and sub-contractor quality systems, and production capabilities.
Prepares letters, reports, presentations, and briefings on quality-related matters for customers and Executive management.
Supports activity to build prototypes of mechanical and electrical systems as required.
Supports technical services and engineering teams to troubleshoot, identify and fix mechanical and electrical problems in support of Engineering and/or Production.
Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
Manages product quality with completing product, company, system, compliance, and surveillance audits; investigating customer complaints; supporting other members of management to develop new product and engineering designs, and manufacturing and training methods.
Maintains the preservation of quality records, statistical reviews, and relevant documentation.
In conjunction with engineering, supports all regulatory standards are met.
Communicates with external quality assurance representatives during on-site inspections.
Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
Provides mentoring and leadership throughout the organization to improve the ownership of total quality across all employees.
Manages the plan, scope, timetable, and execution of internal audits and providing leadership responsibility for the company’s Internal Audit Team.
Manages the company’s Non-Conformance/Corrective Action/Preventive Action system (NC/CAPA).
Manages the Calibration System.
Reviews contracts for quality requirements.
Supports supplier validations by Supply Chain group.
Supports supplier corrective actions by Supply Chain group
Manages the execution aspects of Installation Qualification/Operational Qualification (IQ/OQ) documentation preparation.
Manages customer complaints to determine root cause and reports to appropriate personnel.
Assigns tasks and projected deadlines to department personnel and oversees progress.
Reinforces associates’ awareness of keeping the customer’s end use and needs in mind with every task they do.
Provides value to our customers by using and encouraging associates to use Lean tools and concepts to identify and eliminate waste in all forms. Uses systematic thinking by seeing processes from end to end and works to challenge the status quo to eliminate the root cause of problems. Is involved in individual and/or team activities that involve using Lean tools and concepts to improve the flow of information and material.
Other duties as assigned.
KEY PERFORMANCE METRICS
Internal and external quality audit results
Customer satisfaction as related to quality of products.
Timely resolution and closure of corrective action/preventive action issues
Preventive Action focus to reduce Corrective Action needs
Identify and implement process improvements to improve testing efficiencies.
On time completion of all performance reviews in department
Ability to communicate with employees 1:1 and in large and small groups.
Ability to sit for extended periods of time while working on a computer.
Ability to navigate the manufacturing floor to evaluate products.
Bachelor’s degree in a relevant discipline
Minimum of 5 years’ experience working in a Quality decision-based position in a regulatory environment such as ISO.
Min 5 year’s management experience.
Outstanding communication skills
Great attention to detail and results driven approach.
Excellent organizational and leadership abilities
Excellent numerical skills and understanding of data analysis/statistical methods.
Knowledge of methodologies of quality assurance standards.