Quality System Manager

Job Title: Quality Manager

Location: Holdrege, NE

Duration: Full-Time

Job Description:

Key Responsibilities:

Lead the evaluation, design, and implementation of production and process control strategies to meet plant quality objectives.

Provide quality engineering support for product/process validation and material review board activities.

Review and approve changes to the Device Master Record and validation protocols/results.

Develop and execute strategic quality planning and ensure regulatory compliance.

Guide and oversee quality engineering projects, fostering continuous improvement through Lean, Six Sigma, and statistical problem-solving methods.

Manage vendor qualification and certification processes in collaboration with Supply Management and Supply Quality Engineering teams.

Ensure adherence to all embecta and governmental safety and quality regulations, policies, and procedures.

Provide leadership in team development, mentoring, and effective communication.

Collaborate closely with the Holdrege manufacturing site, Global Quality Management, and other departments.

Serve as the primary engineering liaison during FDA, ISO, and third-party audits, including post-audit follow-up actions.

Perform additional duties as required to support business objectives.

Basic Qualifications:

Bachelor’s degree in Engineering, Quality Assurance, Mathematics/Statistics, or a Science-related field.

Minimum of 3+ years’ experience in medical device manufacturing, validation, and PFMEA.

At least 1+ year of experience in a managerial or supervisory role.

Proficiency in quality tools including MSA, TMV, Capability Analysis, PFMEA, Validation, 8D, and 5Y.

Strong working knowledge of Quality Systems and statistical sampling plans.

Preferred Qualifications:

Master’s degree in a relevant field.

Project Management experience.

Six Sigma certification or experience.

Background in Risk Management and CAPA.

Expertise in root cause analysis and continuous improvement techniques.