Quality Manager

The Quality Manager is responsible for leading the quality system strategy through the creation, adherence, and maintenance of quality standards, developing, and managing a team of high performing quality professionals, and by implementing process improvement programs designed to support the overall organizations quality objectives.

Essential Duties

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.

• Responsible for all quality documents ensuring that they are thorough, accurate and compliant to support all areas of the business and meet quality requirements of existing and new customers.
• Manages quality assurance plans by conducting risk analysis; identifying critical control points and preventive measures; manages root cause analysis, monitoring procedures, corrective actions, and verification procedures. Uses the results to target improvement efforts.
• Supports customer compliance audits, validations, and other quality events such as the instruction and coaching of internal auditors. Serve as liaison during inspections by customer and regulatory agencies.
• Collaborate with both Engineering and Sales on new product development and design review for quality/reliability issues. Creates PPAP (Production Part Approval Process) and/or control plans on new parts as required.
• Proactively investigates, identifies, and implements improved quality practices.
• Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
• Lead, mentor, coach and develop team of Quality Assurance personnel to ensure all quality control procedures are followed on all manufacturing operations.
• Collaborates with leadership team in drafting and maintaining quality operating policies and procedures, objectives, and goals related to the quality system.
• Develops and oversees quality training programs for all personnel. Including but not limited to quality policy and procedures, inspections plans and methods, process variation, root cause analysis, problem solving, etc. Includes developing methods of evaluation of training effectiveness.
• Partners with procurement to ensure quality of materials and services used in manufacturing products is met, prepares, and presents vendor performance reports and establishes vendor status for all critical material and component suppliers.
• Confer with customers representatives as needed to obtain information related to customers quality standards and organization’s ability to meet their requirements.
• Maintain current ISO 9001:2015, ISO 13485:2016 programs and develop and obtain additional certifications as requested.
• Establish and maintain internal quality KPI’s (Cost of quality, PPM defects, etc.)
• Ensures that the quality assurance team receives timely communications of business issues and that two-way communication channels remain open between employees and leaders.
• Other projects and duties as required/assigned.
• Follows Company policies and procedures.

Qualifications

• Bachelor’s Degree in relevant STEM field (technology, engineering) required.
• Certification by the American Society of Quality (ASQ) or as a Certified Quality Engineer (CQE) and/or Certified Manager of Quality/Organizational Excellence (CMQ/OE.)
• 5 years ’experience in both Quality and Lean/Operation Excellence and 3 years in management of a team.
• Broad technical knowledge in the areas of manufacturing processes, quality, and lean concepts.
• Experience and demonstrated competency in Quality Management Systems.
• Motivated goal-oriented leader with proven track record of leading teams to the achievement of quality improvement objectives and change management initiatives.
• Hand-on problem solver with restlessness for the status quo.
• Strong interpersonal skills used to effectively communicate with all levels of the organization, customer, suppliers, and third-party representatives.
• Willingness to drive continuous improvement.
• Unipoint experience a plus.
• Translates regulatory requirements into impactful plans and implement with the organization’s strategic plans and overall company goals.