Quality Manager (ON-SITE)

We are looking for a Quality Manager to join our team and experience what being "The Best Virtual Care Solution" means.

Some of the perks that our employees enjoy include:

• Growth possibilities
• Competitive Health & Welfare Benefits
• Company paid Basic Life insurance: $50,000 for each employee
• Company paid Long-Term Disability benefits
• 401k plan with company match
• Employee Appreciation Days
• Employee Wellness Events
• Competitive pay

Other benefit offering includes:

• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Job Summary:

The Manager of Quality will facilitate efficient production operations by planning, leading, and implementing quality assurance programs. Safeguarding the health of the Engineering Change and ERP systems for medical device manufacturing.

Duties & Responsibilities:

• Manage Quality Control personnel including creation of tasks, managing employee workloads, and providing support for any challenges raised
• Lead quality improvement activities to increase product quality, reduce cost, NC & CAPA resolution, and improve risk management.
• Lead and support staff in the resolution of non-conformance records.
• Participate in Quality Control investigations of product complaints.
• Process owner for device calibration and Quality inspections.
• Establish, monitor, and report on appropriate Key Performance Indicators (KPIs).
• Responsible for ensuring QC resources have the adequate training, education, competency, and experience to perform their related job functions effectively.
• Develop strategies for continuous improvement and personnel development for assigned area of responsibility.
• Review and approve documents that require Quality approval to ensure accuracy, completeness, and compliance with regulatory standards.
• Ensure all Quality Control correspondence is aligned and compliant with GlobalMedpolicies.
• Responsible for interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Performs additional duties at the request of the direct supervisor.

Qualifications:

• Bachelor's Degree in a technical or related field, and 5 years of related experience.

Skills & Competencies:

• At least 3-5 years of prior QA/QC Supervisory experience in a manufacturing environment; medical device experience preferred.
• Working knowledge and application of ISO 13485 and FDA 21 CFR Part 820 quality system requirements.
• Ability to interpret drawings, strong understanding of Geometric Dimensioning and Tolerancing (GD&T), as well as applicable gauging, and inspection methods.
• The use of Statistical software preferably Minitab.
• Working knowledge of FMEA, Root Cause Analysis, SPC, and Poka-Yoke.
• Able to organize and prioritize tasks, must be detail orientated and self-motivated.
• PC literacy including MS Office and Outlook.

Physical Demands & Work Environment:

• Ability to work at least 40 hours per week.
• Ability to lift and/or move at least 25 pounds.
• Occasionally remain in a stationary position throughout day.
• Occasionally move about inside and outside the premises.
• Occasionally work near moving mechanical parts.
• Occasionally work around fumes, airborne particles, or chemicals.