Quality Systems Specialist

Description

• Coordinate and lead generation, completion, and evaluation of standard work documents for assigned areas.
• Monitor training effectiveness and ensure all employees are adequately trained on quality systems and document control procedures.
• Engage with training generation for assigned areas.
• Ensure that quality and safety standards align and that necessary documentation is updated and compliant with applicable regulations.
• Partner with colleagues to ensure that all documents are accurate, compliant, and easily accessible.
• Develop and deliver training programs related to ISO 9001:2015 standards and quality management procedures to staff across departments.
• Review, route, and ensure proper control of all quality management system documents, including policies, procedures, and work instructions.
• Work closely with the Environmental Health & Safety (EHS) team to ensure that Job Safety Analysis (JSA) is completed for applicable procedures and work tasks.
• Monitor industry trends and regulatory changes to maintain ISO 9001:2015 certification and support organizational quality goals.
• Assist with internal and external ISO 9001:2015 audits, providing necessary documentation and support as needed.
• Track, report, and close out CAPA initiatives to ensure that areas of non-conformance are addressed and documented appropriately.
• Partner with leadership to address audit findings by implementing problem-solving strategies for difficult and/or complex challenges.
• Cross-functionally influence decisions for policies, practices, and procedures to ensure compliance and continuous improvement.
• Contribute to continuous improvement initiatives by identifying gaps or inefficiencies in the quality system and recommending process improvements.
• Maintain up-to-date records and ensure that documentation adheres to ISO 9001:2015 requirements.

Requirements

• Strong problem-solving skills for tackling difficult and complex challenges.
• Bachelor’s degree in quality management, Business, Engineering, or a related field.
• Experience in manufacturing or a regulated industry.
• Experience developing and delivering training programs to employees.
• Six Sigma certification in root cause analysis or similar certification.
• Strong interpersonal and communication skills, with the ability to collaborate effectively across departments.
• Proven experience in document control, audit management, and CAPA processes.
• Proficiency with quality management software and Microsoft Office Suite.
• Detail-oriented, organized, and able to manage multiple projects simultaneously.
• Strong knowledge and understanding of ISO 9001:2015 standards and implementation.
• Familiarity with environmental and safety regulations, particularly in relation to Job Safety Analysis.
• Ability to interpret and apply regulatory and quality standards to company processes.
• Ability to work independently, demonstrating self-motivation and initiative.
• At least 3-5 years of experience in quality systems management, preferably in an ISO 9001:2015 or equivalent environment.

Benefits

• Time Off Programs – 22 days Paid Time Off (PTO), 9 Company Holidays, 2 Volunteer Days
• Health Savings Account (HSA) with a company contribution
• Base: $85,000 - $94,000 annually, based on specific compensable factors including, but not limited to education, work experience, and geographic market.
• Wellness Program
• Bonus: This role will be eligible for participation in a discretionary annual bonus program, pursuant to which an employee may be awarded a percentage of their salary based on the company’s performance and their own individual performance.
• 401(k) retirement plan with a 7.5% company contribution
• Medical, Dental, Vision
• Voluntary Benefits (Life, AD&D, Disability)

Training + Development

Interview process

Visa Sponsorship

Security clearance