Quality Manager-Medical

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

Bachelor’s or Master’s Degree in a relevant field of work and five plus years’ experience in Medical Device Manufacturing. In-depth knowledge of ISO 13485 and 21 CFR 820. Experience with Quality techniques such as sampling plan development, statistical process control, inspection systems, instrument calibration, and design of experiments. Good communication and interpersonal skills. Good managerial and supervisory skills. Basic computer experience.

Responsibilities

• Ensures Quality Management System is effective.
• Ensure systems compliance to maintain certification to ISO 13485.
• Responsible for managing site Master Validation Plan, new process validations, and maintenance of existing process validation including validation planning, protocol development and execution, data collection and analysis, and validation results reporting.
• Supports production personnel in the investigation of root causes and corrective actions of internal rejects, and implementation of corrective/preventive actions.
• Ensures CAPA system is maintenance and is effective.
• Administers the Customer Complaint Management system and ensures timely customer response, thorough root cause investigation, definition of corrective/preventative actions and completion of effectiveness checks before complaint closure.
• Immediately notifies Technimark Corporate Quality of any known or potential need for product recall or medical device reporting.
• Ensures internal and external audit findings are addressed in a timely manner and in accordance with customer and/or regulatory agency requirements.
• Oversees product inspection/metrology, functional and/or analytical testing, statistical analysis of result, reporting of results, and determination of acceptability.
• Responsible for the disposition of non-conforming products.
• Develop and administer quality training for all employees.
• Provides direction, training, and support to Quality Engineers and Quality Supervisors.
• Responsible authority for inspection, final disposition, and release of all products.
• Establish and maintain relationships with customers to address issues concerning product quality.
• Ensures trend analysis activities are conducted on periodic, recurring basis for proactive input to CAPA system and Continuous Improvement activities.

Technimark is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, or protected veteran status.

Equal Opportunity Employer
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