Quality Assurance​/Regulatory Affairs Manager

Quality Assurance/Regulatory Affairs Manager

Schedule: Full-Time Day Shift

Position Type: Direct Hire

Develop, implement, and maintain the quality management system to align with the organization’s strategic direction and ensure devices and products comply with customer, quality, regulatory, and statutory requirements.

• Ensure the Presque Isle facility complies with applicable quality and regulatory requirements, including ISO 9001, EN ISO 13485, EU MDD/MDR, MHLW Ordinance No. 169, and FDA/cGMP standards.
• Partner with senior management to set quality policies, procedures, goals, staffing, and budget.
• Lead Quality Assurance and Quality Control functions to support compliance and organizational goals.
• Develop, maintain, and improve the quality management system, including documentation, processes, and work instructions.
• Report quality management system performance, risks, and improvement needs to management and regulatory authorities as required.
• Review technical issues, recommend process improvements, and respond to changing business and market needs.
• Work across departments and with external providers to resolve complaints, nonconformances, and other quality issues.
• Oversee compliance activities for new products, validations, and the control of nonconforming product.
• Monitor applicable standards and regulations and promote awareness of customer and quality requirements throughout the organization.
• Investigate customer complaints, conduct root cause analysis, implement corrective and preventive actions, and prepare customer responses.
• Serve as the facility liaison on quality management matters and perform other duties as assigned.

• Bachelor’s degree from a four-year college or university.
• At least 10 years of related experience or training, or an equivalent combination of education and experience.

• Proven ability to manage complex quality management systems, including ISO 9001, EN ISO 13485, 21 CFR 820, MDD, MDR, MHLW, and KFDA.
• Knowledge of regulatory requirements for the devices produced and markets served.
• Ability to support third-party audits by customers, registrars, and regulatory bodies.
• Ability to lead quality assurance and quality control functions.
• Ability to multitask and prioritize to meet organizational goals.
• Analytical skills, including Six Sigma, process capability, and data analysis.
• Knowledge of process and product qualification and validation.
• Knowledge of device and product design and development.
• Strong organizational skills and attention to detail.
• Extensive knowledge of engineering, manufacturing, and product realization.
• Proficiency in Microsoft Office or similar software.
• Strong verbal and written communication skills.
• Proficiency in time management, planning, and scheduling.
• Proficiency in data interpretation and statistical analysis.
• Proficiency in technical and report writing.
• Proficiency in root cause analysis and problem-solving.
• Salary range of $60,000 to $80,000 per year, depending on experience