Senior Quality Manager, Medical Devices & Compliance

Technimark; North Carolina; On-site; USD 75,000 - 95,000; Full time

Job summary

Technimark, located in North Carolina, is seeking a qualified professional for Quality Management in Medical Device Manufacturing. The role requires a Bachelor’s or Master’s Degree and at least five years of relevant experience.

The successful candidate will ensure compliance with ISO standards, manage process validations, and lead quality training for employees. Ideal qualifications include in-depth knowledge of quality techniques, strong communication skills, and managerial experience.

Qualifications

• Five plus years of experience in Medical Device Manufacturing.
• In-depth knowledge of ISO 13485 and 21 CFR 820.
• Experience with quality techniques such as sampling plan development and instrument calibration.

Responsibilities

• Ensures Quality Management System is effective.
• Responsible for managing site Master Validation Plan and process validations.
• Supports production personnel in investigating root causes and corrective actions.

Skills

Quality management skills

Statistical process control

Good communication skills

Managerial skills

Education

Bachelor’s or Master’s Degree in a relevant field

Job description

Technimark, located in North Carolina, is seeking a qualified professional for Quality Management in Medical Device Manufacturing. The role requires a Bachelor’s or Master’s Degree and at least five years of relevant experience.

The successful candidate will ensure compliance with ISO standards, manage process validations, and lead quality training for employees. Ideal qualifications include in-depth knowledge of quality techniques, strong communication skills, and managerial experience.