Director of Quality Assurance and Compliance

Summary

Mac Medical manufactures the highest quality medical equipment available. We produce an extensive line of standard and customized products with cutting-edge technology and are committed to continuous improvement and innovation. We are seeking a dedicated, energetic, out-going, enthusiastic Director of Quality Assurance and Regulatory Compliance professional to join our team. As a Director, you will be essential in developing and implementing quality assurance and inspection control processes and regulatory compliance requirements.

This is a tremendous opportunity for a proven successful quality assurance professional. The Director of Quality Assurance assists in developing a climate of enthusiasm, teamwork and cooperation among employees.

The Director of QA establishes quality systems and standards by adhering to FDA and ISO regulations, develops, implements and maintaining internal processes and procedures and customer requirements to meet or exceed all regulatory compliance requirements in the industry. The Director of QA will collaborate with other members of management, production operators and engineers then enforces quality standards, controls, documentation utilizing and maintain information in the ERP system.

Essential Functions:

· Develop, implement, manage and integrated a QMS for the manufacturing plant that meets the requirements of ISO9001-2008 and the FDA CFR 21 Part 820 cGMP (Good Manufacturing Practice).

· Create, revive, review & submit FDA 510k Class I, Class II & Class III Medical Devices on the behalf of MAC Medical Inc. and our OEM customers.

· Ensure process standards are established to meet or exceed compliance and legal standards for certification for FDA, UL, ETL, NSF and CSA.

· Medical Device Reports (MDR’s) and EU Vigilance Reports to the FDA and other regulatory bodies.

· Contribute to the creation and implementation of best practice manufacturing vision, strategy, policies, processes and procedures to aid and improve operational performance.

· Develop, implement and document procedures for process control, process improvement, testing and inspections.

· Serves as the primary quality control resource for problem identification, resolution, loss reporting and continuous improvement.

· Initiated and implemented quality improvement activities such as, Kaizen & Six Sigma projects to raise the performance of the company’s product lines.

· Educate and train employees on product quality standards and their responsibilities.

· Performs root cause analysis and other problem-solving activities to identify effective corrective action and resolve problems action and process improvements.

· Conduct risk assessments of processes and tasks in departments.

· Responsible to ensure MAC Medical Inc. operates in accordance with any health, safety and environmental policies and procedures to ensure the safety and well being of staff and visitors of MAC Medical Inc.

· Manage, coach and develop a high performing manufacturing team that meets agreed objectives and delivers best practice results, added value and continuous improvements throughout MAC Medical.

· Set department objectives/KPIs and review and assess ongoing performance of direct reports.

· Manage and lead the Quality Team, ensuring adequate staffing levels, managing holiday allowances, recruitment, training, development, appraisal, attendance, disciplinary issues and daily supervision to maximize efficient productivity.

· Supports the Engineering Department by participating in design development projects representing quality assurance and the customer.

· Identify business improvement opportunities within the organization and make recommendations to improve process.

· Established and implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.

· Established collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.

· Develop quality planning methods for all product lines.

· Develop process certification standards and assist in process certification (FDA, UL, ETL, NSF, and CSA).

· Monitor vendor performance and establish criteria and rating system for critical vendors.

· Review customer purchase orders, contracts and change requests and ensure that the necessary criteria and provisions are included in quality and process plans.

· Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel.

· Oversee the calibration and testing programs.

· Conduct and participate in internal and external quality audits, then reports quality issues, trends and losses.

· Review suppliers purchase orders and establish supplier quality requirements.

· Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.

· Manage contractors on site to ensure they meet legal and company requirements.

Other Job Duties included but not limited to:

· Develop, implement, and manage the Quality Management Software.

· Manage and Support MAC Medical Inc. ERP System – (Modes, reports, backups, restore, testing upgrades, and support install teams when needed)

· Oversees the janitorial of MAC Medical Inc. – Millstadt Locations

· Oversees the company vehicles and maintenance requirements

· Other duties dictated by senior management

Benefits:

• Health insurance
• Dental insurance
• Vision insurance
• Retirement plan
• Paid time off

This Job Is Ideal for Someone Who Is:

• Dependable — more reliable than spontaneous
• Detail-oriented — would rather focus on the details of work than the bigger picture
• Achievement-oriented — enjoys taking on challenges, even if they might fail
• Autonomous/Independent — enjoys working with little direction
• Innovative — prefers working in unconventional ways or on tasks that require creativity
• High stress tolerance — thrives in a high-pressure environment

This Company Describes Its Culture as:

• Stable — traditional, stable, strong processes
• Outcome-oriented — results-focused with strong performance culture
• Aggressive — competitive and growth-oriented
• Innovative — innovative and risk-taking
• Detail-oriented — quality and precision-focused