Job Description

Job Summary:

We are seeking a Quality Systems Manager who is responsible for developing, implementing, and maintaining the Quality Management System (QMS) to ensure compliance with relevant industry standards, regulatory requirements, and company policies. This role leads quality improvement initiatives, audits, and documentation systems to drive continuous improvement across all business functions.

Key Responsibilities:

Quality Management System (QMS):

• Develop, implement, and maintain the QMS in compliance with factory standard.
• Ensure QMS progresses toward meeting ISO9001 standards.
• Manage document control systems to ensure proper creation, approval, revision, and archiving of quality records.

Compliance & Audits:

• Lead internal audits and support external audits (e.g., regulatory bodies, customers, certification bodies).
• Ensure compliance with local, national, and international regulations and standards.

Training & Development:

• Train employees on quality processes, regulatory requirements, and standard operating procedures (SOPs).
• Promote a culture of quality and continuous improvement throughout the organization.

CAPA & Risk Management:

• Oversee the Corrective and Preventive Action (CAPA) process to identify root causes and implement effective solutions.
• Conduct risk assessments and manage risk mitigation strategies.

Continuous Improvement:

• Identify areas for improvement and drive quality improvement projects using tools such as Six Sigma, Lean, or Kaizen.
• Analyze quality data and trends to support process optimization.

Supplier & Customer Quality:

• Collaborate with suppliers and customers to ensure quality standards are met.
• Evaluate and monitor supplier performance and compliance.

Qualifications:

• Bachelor’s degree in Engineering, Quality Assurance, or a related field.
• 5+ years of experience in quality management systems, with 2+ years in a leadership role.
• Strong knowledge of quality standards (e.g., ISO 9001, ISO 13485, FDA QSR, GMP).
• Experience with audit processes and regulatory compliance.
• Excellent communication, leadership, and problem-solving skills.
• Certification in Quality (e.g., ASQ CQE, CQA, Six Sigma) is a plus.

Preferred Qualifications:

• Knowledge of GD&T, SPC, or FMEA.
• Strong knowledge of quality tools and methodologies (e.g., Six Sigma, Lean, DMAIC).
• Familiarity with industry standards and regulations (e.g., ISO, ASME, AWS).
• Proficient in statistical analysis and quality software (e.g., Minitab, SPC software).

The base salary range for this role is $100,700 to $151,100. This base salary range represents the low and high end of the base salary range for this position. Actual base salary offered will vary based on various factors including but not limited to location, level, job-related knowledge, skills, experience, and performance.

This job description describes the general nature and level of work expected of a person assigned to this position. All job requirements listed indicate the minimum level of knowledge, skills and/or ability deemed necessary to perform the job proficiently. Employees may be required to perform any other job-related duties as requested by their supervisor.

It is the policy of FORTNA and its affiliated companies to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, pregnancy or pregnancy-related condition, status with regard to public assistance, veteran status, citizenship status (if authorized to work in the U.S.), or any other characteristic protected by federal, state or local law. In addition, FORTNA will provide reasonable accommodations for qualified individuals with disabilities.