Quality Manager - 1st Shift jnf

Essential Duties and Responsibilities:

· Develop, implement, maintain, and continually improve a comprehensive quality management system (QMS) to ensure consistent product quality and compliance with regulatory and ISO standards.

· Establish quality standards for products and processes and suggest modifications to prevent defects in components and final products.

· Develop and initiate internal standards and processes for inspection, testing and evaluation Audit production processes, to ensure established quality standards are met.

· Create and utilize risk mitigations tools, including, but not limited to process FMEA’s, process control plans, and visual standards.

· Develop plant COQ (Cost of Quality) metrics and tracking methodology

· Create first article / PPAP submissions for customers.

· Manage nonconformance. Conduct root cause analysis and coordinate implementation of corrective actions. Follow up to assure that corrective actions are in place and effective.

· Measure parts, complete process capability studies, conduct statistical process analysis, interpret results, and make recommendations regarding dimensional part tolerances.

· Develop and initiate quality control plans using engineering product drawings, process diagrams, and technical specifications to meet company requirements for ISO and customer requirements.

· Analyze quality data, identify problem areas, and assist in improving manufacturing processes and methods that affect quality.

· Participate in cross functional product launch activities. Lead the APQP process and establish quality plans that manage potential risks.

· Apply continuous improvement methods to enhance manufacturing processes, quality, reliability, and/or cost effectiveness.

· Maintain professional working relations and effective communication with all team members, managers, vendors, customers, and regulatory agencies.

· Lead regulatory (ISO:13485:2016, FDA and cGMP) and customer audits.

· Provide disposition of incoming, non-conforming materials in a timely manner and assure proper preventive actions are taken as needed.

· Establish and implement supplier quality management system. Work with suppliers to reduce and eliminate defects.

· Work with engineering and operations to develop methods and procedures for evaluation of processes and equipment to meet the required quality capability.

· Maintain appropriate history and records of quality issues and process improvements.

· Perform required equipment qualifications (EQ) and process qualifications (PQ).

· Design, develop, and train employees in the ISO 13485:2016 quality program.

· Engage and contribute to the continuous improvement activities by participating and providing thoughtful consideration and suggestions for improvements throughout our business.

· Other duties as assigned

Qualifications Required:

· College degree preferred. Quality certifications are desired

· 5+years of progressive quality experience, preferably in printing or converting industry

· 3+ years of experience working in a manufacturing environment with ISO 13485:2016 quality system or 21 CFR 820 environment

· Experience using APQP tools and methodologies

· Proficiency with MS Office Suite (MS Word, Excel, Outlook)

· Highly organized with meticulous attention to detail

· Self-starter. Proactive nature. Ability to work independently

· Project management skills and experience

· Judgement is required in resolving complex problems based on experience

· Customer focused mentality

· Professional presentation skills

· Proven written and oral communication skills

· Must possess above average mathematical and analytical skills

· Excellent track record of attendance and punctuality

· Sense of urgency and overall customer satisfaction focus

Qualifications Desired:

· Experience with FDA requirements

· Knowledge of label industry software (LabelTraxx)

· Ability to interpret drawings and specifications

Success Factors/Job Competencies:

· Friendly, outgoing personality

· Clear communication skills

· Time management – the ability to organize and manage multiple priorities

· Ability to work well in a team environment

· Knowledge of the products and manufacturing processes

· Ability to remain patient when confronted with challenging situations

· Strong listening skills

· Open-minded personality with motivation to learn and apply learned concepts

· Tenacity – the willingness to do what needs to be done

· Goal-oriented focus

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Physical demands - While performing the duties of this job the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk; and use hands to finger, handle, or feel. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required include close vision, distance vision, and color vision.

· Work Environment – The noise level in the working environment is normally quiet.

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