Quality Engineer - Compliance

JOB DESCRIPTION

Location Address:

600 Vista Drive, Sparta, Tennessee 38583

Work Shift:

8hr-1st Shift (United States of America)The Quality Engineer – Compliance will collaborate closely with various departments to manage part creation, provide part quotes, estimate annual volumes, and plan capacity to meet production demands. The role will also ensure compliance with regulatory standards and documentation in accordance to FDA pharmaceutical requirements and maintain records of compliance for USP testing, Material test data sheets, and new product requirements for testing.

1. Part Creation and Development:
• Collaborate with the engineering and design teams to oversee the part-creation process, ensuring all quality standards are met.
• Participate in design reviews and provide input on manufacturability and quality considerations.
• Maintain documentation and records related to part specifications, changes, and approvals.
2. Quality Complaints:
• Intake Quality complaints and leads Root Cause Investigations
• Implement and train on Corrective Actions
• Enter complaints into the Quality database
3. Documentation and Reporting:
• Maintain detailed records of quality inspections, test results, and corrective actions.
• Prepare pricing reports and analysis for management review.
• Ensure accurate documentation for compliance with industry standards and regulatory requirements.
4. Continuous Improvement:
• Help identify initiatives for continuous improvement in quality processes, reducing waste and enhancing efficiency.
• Utilize data-driven approaches to identify areas for improvement and solutions.
• Foster a culture of quality and continuous improvement throughout the organization.
5. Customer and Supplier Interaction:
• Address customer inquiries related to product quality and pricing.
• Liaise with suppliers to negotiate material costs and ensure quality standards.
6. Cross-functional Collaboration:
• Work closely with the product development team to ensure new products meet quality and cost expectations.
• Collaborate with procurement and supply chain teams to manage raw material quality and pricing.
7. Training and Development:
• Provide training and support to staff on quality standards, procedures, and best practices.
• Stay updated on industry trends and advancements in quality management and incorporate relevant practices into the company’s operations.

• Strong knowledge of quality management systems and standards (, ISO 9001).
• Experience with part creation, quoting, and capacity planning in a manufacturing setting.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and interpersonal skills, with the ability to work collaboratively across departments.
• Proficiency in quality management software and tools.

Education/Experience

• Bachelor’s degree in Engineering, Quality Management, or a related field preferred.
• Minimum of 2 years of experience in quality within a manufacturing environment, preferably in the plastics industry.

Work Environment

While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts and vibration. The noise level in the work environment and job site can be loud. Employee could be exposed to seasonal weather conditions if required to go outdoors. Proper use of PPE is required in Production area at all times.

Altium Packaging, Our Culture Differentiates Us!

We incorporate our Guiding Principles into all aspects and at all levels of the organization and use them as a framework for decision-making. We believe our Guiding Principles foster a culture of excellence that benefits both employees and customers.

Our Guiding Principles

• Act with Integrity & in Compliance
• Drive Value Creation
• Be Disciplined Entrepreneurs
• Focus on the Customer
• Act with Humility
• Treat others with Dignity and Respect
• Seeking Fulfillment in your Work

We Believe in Rewarding our Most Important Resource – Our People!

We show our commitment to Total Rewards by providing a competitive, comprehensive benefits package. In addition to medical, dental and vision plans, company holidays and vacation days, tuition reimbursement, learning and training opportunities, bonus potential, and a 401(k) plan with company contributions, Altium Packaging locations offer rewards and recognition programs and opportunities to make a difference in the community.