Quality Assurance Manager

Major Responsibilities

• Develop, implement, and maintain quality assurance policies, procedures, and standards to ensure compliance with AS9100D/ISO 9001, and/or ISO 13485 requirements.
• Manage quality system processes, such as MRB/DMR, RMAs, CAPAs, internal audits, and corrective/preventive actions.
• Monitor key quality metrics (KPIs) and drive continuous improvement initiatives to enhance product quality and process efficiency.
• Oversee and support the root cause analyses process and implementation of corrective actions.
• Oversee customer quality requirements, ensuring effective communication throughout the organization and supply chain.
• Communicate with and provide quality assurance expertise to customers, suppliers, engineering, manufacturing, purchasing, and sales.
• Provide face-to-face technical expertise for visits to high-value and strategic customers.
• Lead internal audits, and certifications to maintain industry and customer standards.
• Establish training and development of quality personnel (Engineers, Technicians, etc.) ensuring competency in quality assurance practices and problem-solving methodologies.
• Provide regular reports on quality performance, compliance status, and improvement initiatives to senior management.
• Proactively looks for opportunities to utilize new or existing concepts to improve product and process quality.
• Serve as a safety role model by promoting and ensuring a safe work environment.

Qualifications And Skills

• Education & Experience: Bachelor’s degree in engineering, quality management, or a related field (preferred). Minimum of 5 years of experience in quality assurance within a manufacturing environment. Minimum of 3 years managing and mentoring Quality personnel i.e. Quality Engineers, Technicians, etc.
• Knowledge and application of AS9100D, ISO 9001, ISO 13485, or equivalent quality management systems.
• Knowledge of Advanced Quality Planning Technical & Leadership Skills: Strong knowledge of quality assurance methodologies, problem-solving techniques such as Critical Thinking, 5W/1H, and 8D methods, SPC, PPAPs. Proven experience with Lean/Six Sigma, and mistake-proofing concepts i.e. Process mapping, FMEAs, DOE’s, Control plans.
• Excellent analytical, problem-solving, and decision-making abilities. Strong project management skills with the ability to handle multiple priorities. Effective communication and leadership skills to engage with all levels of the organization. Communicates clearly and succinctly in a variety of communication methods and settings.
• Proficiency in ERP systems, regulatory portals, PowerPoint, Excel, and technical research tools. Excellent time management skills concentrating on priorities and overall planning, awareness, and response to what is due now, short, and long term. Good business acumen, understands policies, practices, technology, trends, and information and how those affect the business.

Targeted Salary Range

$140,000-$150,000 + bonus

Benefits

• Medical/Rx
• Dental
• Vision
• Flexible Spending Accounts
• Basic Life/AD&D (includes coverage for dependents 100% Company paid)
• Short-Term Disability
• Long-Term Disability (100% Company paid)
• Supplemental Life/AD&D
• 401(k) with Company match
• Tuition assistance after 1 year
• Paid time off
• 11 paid holidays