Director of Quality

Summary

• Manage all quality activities including quality assurance and quality control.
• Ensure the continued effectiveness and improvement of the Quality Management System.
• Serve as Management Representative for the organization.
• Promote a culture of Quality throughout the organization.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Leadership – Strong ability to lead all employees of the department and is responsible for the performance management and hiring of the employees within quality.
• Responsible for creation, implementation and maintenance of the Quality System processes, in compliance with FDA 21 CFR Part 820, ISO 13485 and customer requirements.
  • Systems include Corrective and Preventive Action, Non-conformance, Validation and Qualification, Management Review, Document and Record Control, Risk Management Activities, Training and Resource Management, Supplier Management, Internal and External Audit System, Calibration, Inspection, RMA and Customer Complaints

• Promotes quality awareness and continuous improvement.
• Develops, coaches and trains personnel to ensure that adequate compliance and technical understanding is built into day-to-day operations.
• Positively influence and direct internal and external stakeholders.
• Ability to analyze issues and problem solve.
• Ensure product meets specified requirements.
• Strong written and verbal communication skills.

Qualifications 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.

• Minimum five years of work experience with an ISO13485 certified and FDA regulated environment.
• Minimum five years of CNC machining environment and industry experience.
• Minimum five years of engineering and/or quality management experience.
• Secondary Degree, certification, or certificate focused in Quality preferred (CQM, CQE and CQI).

Core Competencies:

• Thorough knowledge and understanding of quality philosophies, principles, methods, and tools.
• Understanding of various inspection/measurement methods, blueprint reading and GD&T.
• Knowledge and understanding of ISO 13485 and 21 CFR Part 820.
• Ability to communicate extremely well across all levels and departments.
• Ability to lead and develop personnel.
• Strong interpersonal skills.
• Strong organizational skills.
• Self-motivated with high degree of accountability.

Education and/or Experience

• Bachelor of Science Degree in Engineering or similar discipline preferred

Language Skills

• Ability to read, analyze, and interpret quality regulations, customer requirements and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. 

Reasoning Ability

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills

• Proficient with Microsoft Office applications, including Word, Excel, and PowerPoint.

Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit. Specific vision abilities required by this job include ability to adjust focus.

Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Additional Notes

ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success.  All employees of ARCH Global Precision are employed on an at-will basis.

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.