Summary: Reporting to the Plant Manager, the quality manager plans, coordinates, and directs quality program which is designed to ensure quality control and quality assurance of the production of products consistent with established standards by performing the following duties personally, through direct reports, or collaboratively through staff peers.

Essential Duties and Responsibilities include the following:

• Function as the facility’s ISO Management Representative
• Coordination of root cause analysis, corrective action, and follow up for customer complaints, supplier corrective action requests, and significant yield loss events.
• Maintain functioning supplier quality management process.
• Set plant level quality objectives and targets.
• Lead plant quality team monitoring and achieving objectives and targets.
• Act as subject matter expert for Interpretation of ISO requirements and customer specifications.
• Approve or deny internal variances based on in depth understanding of impact to final product.
• Accountable for ensuring proper deviation or change process is followed for product impacting changes.
• Gatekeeper for ensuring process qualifications (IQ, OQ, & PQ) are thorough and satisfactorily completed before new product production occurs.
• Manages controls (labels, locations, ERP systems) to ensure the release of quality products to customers.
• Review and recommend disposition of non-conforming materials.
• Leads lab testing team
• Development and initiation of standards and methods for inspection, testing, and evaluation.
• Develop the in-process and final inspection plan for intermediates and final products.
• Review of documentation for compliance with stated requirements, including vendor quality manuals and company quality records.
• Lead facilitator for external customer and quality certification audits.
• Accountable for timely lab testing to allow for quick detection of upset conditions and to allow for on-time shipping.
• Maintain a working knowledge of government and industry quality codes and standards.
• Design and implement quality training programs to key personnel in conjunction with managers, including the incoming, in-process and final inspections.
• Interface with customers, salespeople, and suppliers on quality issues.
• Any other tasks the organization requires to be performed.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Minimum of 3 years of direct experience with ISO quality standards
• Minimum of 3 years of direct experience with cGMP
• Minimum of 5 years of manufacturing experience
• Preferred experience in people leadership.
• Preferred experience in FDA and ISO 13485

Education:

Bachelor of Science Degree (B.S.) in engineering or quality management.

Other degrees considered if accompanied by 10+ years of experience in a quality related role in a manufacturing environment.

Language Ability: Ability to read, write and comprehend English.

Mathematical Ability: Comprehensive understanding of intermediate mathematics including statistical analysis, fractions, percentages, ratios, and proportions.

Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills: Fluency in Microsoft Office (Outlook, Word, Excel, PowerPoint, etc.)