Overview
Associate Clinical Quality Mgr Jobs in Rockford, IL at PCI Pharma Services
Position Requirements
Essential Functions:
Lead the APQP Development process (PFD, PFMEA, Control Plans, etc.) for specific programs assigned
Work within the company policies to manage the quality assurance aspects of new product introduction
Provide oversight of the manufacture of products to ensure that engineering documentation is consistent with manufacturing methods employed
Report, coordinate and chair APQP meetings, complete the APQP checklist and document open issues on the APQP action item matrix
Develop test methods/procedures to support product validation efforts
Perform performance validation tests to meet customer specifications
Generate test reports of performance validation tests
Act as quality lead for customer program reviews throughout the development process
Develops and implements programs to assess and improve the quality of products, components, materials and/or operations.
Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
Conducts quality control (QC) inspections on products, materials, components, parts, etc., at various stages of the production process to ensure compliance with established quality and reliability standards.
Cross-Functional Collaboration: Ensures feedback is integrated from design, R&D, production, and other teams for continuous improvement
Work with outside suppliers and manufacturing plants to complete and approve supplier PPAP submissions
When needed, participate on site at suppliers for program and/or critical issues requiring assistance.
Assist with the development, testing, or modifications of prototype or production parts.
Direct supplier to Set up appropriate testing procedures and record all necessary data, calibrate test equipment as needed, establish procedures for technical measuring.
Lead the development and implementation of a Process Improvement Initiatives
Develop and document new business process to support the ARV Quality System
Support manufacturing activities at our partners and suppliers facilities
Support and adhere to all company safety and environmental regulations & policies
Undertake other duties as determined by the Quality Director or his/her delegate
Supervisory Responsibilities:
None
Minimum Qualifications:
Knowledge, Skills and Abilities (as demonstrated through experience, training and/or testing)
Knowledge and experience working with AS9100D/IATF16949/ISO9001 Standard.
Knowledge of APQP and AS9145
Knowledge of Systems based design and related Standards/Processes
Technical Analysis: Expert in statistical tools, process capability
Problem Solving: Uses root cause analysis tools like 8D, 5 Why, and Ishikawa.
Solid understanding of Continuous Improvement with proven track record of implementation
Effective and professional communication and organization skills
Good analytical and problem solving skills
Ability to present to clients and internal stakeholders
Familiarity of the US DoD process and procedures for vehicle development and acquisition.
Practical ‘hands on’ attitude with the ability to operate independently.
Must promote collaboration and facilitate teamwork across the organization and its external service providers.
Must be tactful, diplomatic, and work with integrity, honesty, and respect for others.
Customer Oriented: Must display exceptional listening and analytical skills in order to understand customer concerns and needs with the ability to respond promptly and effectively to those needs.
High level of self-motivation and standards with the ability to multi-task; balancing “analysis” with “doing”. Must be adaptable and able to prioritize and work under pressure to meet deadlines. Work on own initiative.
Education:
Bachelor’s degree in Engineering, Business Administration or high school diploma with at least 10 years relevant experience.
Experience:
5 or more years of relevant manufacturing experience
5 or more years of leadership / supervisory / managerial experience
Experience of working in a multi-national, multi-organizational and corporate environment
Experience with quality, engineering and supply chain management in a highly regulated industry
Job Types: Full-time, Contract
Pay: $50.00 – $60.00 per hour
Expected hours: 40 per week
Schedule:
8 hour shift
Day shift
Work Location: In person
Title: Associate Clinical Quality Mgr
Company: PCI Pharma Services
Location: Rockford, IL
