Full-Time APU Quality Manager

Position Purpose: Plan, coordinate and manage assigned projects ensuring continuous production and distribution of products consistent with established standards. Supervise and coordinate Quality staff. Evaluate compliance with specifications, operating procedures, and standards. Duties are performed personally or through subordinate staff.

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:

• Coordinate and execute objectives maximizing product quality and operating system efficiency to minimize costs.
• Identify and coordinate resolution of system inefficiencies contributing to increased quality costs.
• Coordinate execution of validations, including written protocols.
• Coordinate execution and participate in investigations regarding customer complaints.
• Assess results of Customer Complaint investigations & Corrective Actions for application, validity, and conformance to FDA, ISO, and Customer requirements.
• Ensure CAPA system effectiveness using problem-solving techniques (FMEA, DOE, Cause & Effect, Flow Charts, SPC) to reduce internal/external failures.
• Analyze data to determine adequacy of standards and propose quality improvements, including analysis of inspection methods and sample plans.
• Plan, promote, and organize training for internal departments and customers on quality activities (basic statistics, DOE, GR&R, Sample Plan designation, validation creation).
• Interact with customers to assure mutual interpretation of requirements.
• Ensure ISO and FDA QSR quality systems compliance.
• Generate monthly/weekly reports as required.
• Execute responsibilities as defined in the company quality operating system.
• Support and maintain company policies (FDA, ISO, Health & Safety, Continuous Improvement).
• Review and approve documents as defined in the Quality Management System.
• Coordinate and evaluate the Quality department.
• Carry out supervisory responsibilities according to company policies and laws.
• Participate in interviewing, hiring, and training employees; planning, assigning, directing tasks; appraising performance; rewarding, and disciplining employees; addressing complaints and resolving problems.
• Represent the Quality Department in customer and ISO audits.
• Perform other duties as assigned.

POSITION REQUIREMENTS:

• Bachelor's degree in Engineering or related field.
• Minimum 5 years related work experience, including at least one year in a supervisory role.
• Lean Manufacturing experience (including Six Sigma training) and/or certifications preferred.
• Database software (e.g., SAP) experience.
• Ability to lift 30 lbs. and stand/sit/walk up to 80% of shift.

PREFERRED KNOWLEDGE/SKILLS:

• Application of advanced mathematical concepts and intermediate statistical knowledge.
• Excellent communication (English – understand, read, write, speak).
• Coaching and mentoring skills (individual/group).
• Demonstrated organizational skills and ability to meet strict deadlines.
• Proficiency in common software tools (Word, Excel, PowerPoint).
• Understanding of role's interrelation with Quality department function, goals, and objectives.

WORK ENVIRONMENT:

• Office and clean room environment with moderate noise levels.
• Appropriate Personal Protective Equipment (PPE) and cleanroom apparel required.
• Travel between office, production departments, and company buildings.

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