Quality Manager

SCHLEIFRING MEDICAL SYSTEMS, LLC•Elgin, IL

just now•Onsite

About The Position

The QA Manager is responsible for overseeing the Quality Assurance function for a manufacturing organization producing precision components for medical devices. This role ensures compliance with AS9100, ISO 9001, and applicable regulatory requirements, while driving continuous improvement initiatives to maintain product integrity and customer satisfaction. In this role they will work closely with Materials, Engineering, Production and Quality to ensure Quality Programs’ accuracy.

Requirements

Bachelor’s degree in engineering, Quality Management, or related field
4–10 years related experience and/or training, or equivalent combination of education and experience.
Strong knowledge of lean manufacturing, Six Sigma, and continuous improvement methodologies
Strong knowledge of AS9100, ISO 9001 and FDA requirements.
Experience with audits, CAPA, risk management and validation of processes
Familiarity of ERP and QMS software systems.
Excellent problem-solving, communication, and organizational skills
Ability to manage multiple projects and work in a fast-paced environment
Ability to perform calculations related to measurements, tolerances, and production quantities.
Understanding ratios, proportions, and percentages for yield and defect analysis.
Ability to interpret control charts, histograms, and Pareto charts.
Experience with trend analysis and root cause analysis using quantitative data.
Knowledge of statistical process control (SPC).
Understanding of units, conversions, and precision measurements.
Familiarity with geometric tolerancing and dimensional inspection.
Demonstrates the ability to analyze inventory inaccuracies and reason through possible causes of inaccurate counts.
Must be able to grasp Production’s processes and procedures as a means to determine root causes.
Knowledge of Inventory software; Manufacturing software; Order Processing systems; Payroll systems; Project Management software; Spreadsheet software, QMS Systems, and Statistical Software Minitab.
Person must sit; use hands to enter data; hear doorbells and equipment moving around them. Frequently required to reach with hands and arms; required to stand, walk, climb, stoop and kneel at times.
Person must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50lbs; and often move 75+ pounds using lift equipment provided.
Specific vision abilities required by this job include close vision, distance vision, peripheral vision and depth perception.

Nice To Haves

Aerospace experience or knowledge helpful

Responsibilities

Maintain and continuously improve the QMS to ensure compliance with AS9100 and ISO 9001 standards.
Manage internal audits, supplier audits, and coordinate external audits (registrar, regulatory bodies).
Ensure proper document control, record retention, and configuration management
Ensure adherence to customer-specific requirements and applicable regulatory standards.
Oversee Corrective and Preventive Actions (CAPA), Non-Conformance Reports (NCR), and root cause analysis.
Monitor compliance with risk management and traceability requirements for components.
Lead, mentor, and develop QA team members, including quality engineers, inspectors, and technicians.
Provide training on quality standards, inspection techniques, and continuous improvement tools.
Oversee incoming material inspection, in-process quality checks, and final product release.
Review and approve quality plans, inspection criteria, and validation protocols.
Ensure proper calibration and maintenance of measuring equipment.
Drive initiatives using Lean, Six Sigma, and other quality tools to reduce defects and improve efficiency.
Implement metrics and dashboards to monitor quality performance and trends.
Manage customer complaints and ensure timely resolution with root cause analysis and corrective actions.
Evaluate and qualify suppliers, monitor supplier performance and compliance with quality standards.
Supervise QA staff, including inspectors and quality engineers.
Provide training on quality standards, procedures, and best practices.
Any and all duties assigned.

Benefits

Paid time off (PTO)
10 Paid Holidays
Company Bonus Plan
401 (K) Plan
Medical, Dental, Vision and Life Insurance
Voluntary Benefits: Accident/Critical Illness/Hospital Indemnity Benefits, Identity & Fraud Protection and Legal Plans
Tuition reimbursement
Flexible Spending Account (FSA)
Employee Assistance Program
Short-Term and Long-Term Disability