POSITION SUMMARY

The Quality Control Manager is a hands-on, problem solving manager responsible for the quality control department. The Quality Control Manager works closely with Engineering, New Product Introduction, Manufacturing, and Supply Chain teams to drive continuous quality improvement. Responsibilities include Quality Management System (QMS) execution to maintain compliance with ISO9001, ISO13485, customer requirements and cGMP. Additional responsibilities include quality data collection and reporting, managing customer and agency audits, product/process qualification, and documentation control. The Quality Control Manager will work with direct reports to ensure process and workmanship standards are continuously maintained.

ESSENTIAL FUNCTIONS

• Maintain ISO 9001:2015 and ISO 13485:2016 Certifications and requirements.
• Maintain robust Quality Manual and address continual improvement.
• Develop and manage quality assurance metrics for performance improvement initiatives.
• Review and update standard operating procedures.
• Maintain and oversee proper document control.
• Manage customer and compliance agency audits.
• Drive Change Controls, Deviations, and CAPAs from initiation to completion.
• Represent Quality Control on cross-functional project teams.
• Coordinate supplier and internal audit controls and conduct reviews as necessary.
• Report to Senior Management regarding nonconformance of products or processes, daily production quality, root cause analyses, and quality trends.
• Work closely with Engineering, NPI, Manufacturing, and Supply Chain to improve overall quality.
• Ensure inspection methods are consistent and effective.
• Team lead and prioritize all RMA and MRB activities with appropriate department stakeholders.
• Stop production if serious product defects are present.
• Effectively manage and mentor quality team reports.
• Coordinate and manage all aspects of process/product validation including IQ, OQ, PQ, PFMEA, Risk Analysis, PPAP, and Regulatory Compliance with cross-departmental support.

POSITION QUALIFICATIONS

• Team Builder – Ability to convince a group of people to work toward a goal.
• Analytical Skills – Ability to use thinking and reasoning to solve a problem.
• Communication (written and oral) – Ability to communicate clearly, effectively, and concisely with others.
• Accountability – Ability to accept responsibility and account for his/her actions.
• Leadership - Ability to influence others to perform their jobs effectively and to be responsible for making decisions.
• Goal Oriented - Ability to focus on a goal and obtain a pre-determined result.
• Decision Making - Ability to make critical decisions while following company procedures.
• Accuracy - Ability to perform work accurately and thoroughly.
• Judgement - The ability to formulate a sound decision using the available information.
• Patience - Ability to act calmly under stress and strain, and of not being hasty or impetuous.
• Self-Motivated - Ability to be internally inspired to perform a task to the best of one’s ability using his or her own drive or initiative.
• Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.

SKILLS & ABILITIES
Education: BA with preference to engineering degree.
Experience: Five years in Quality Management.
Computer Skills: Microsoft Suite, database development.