Manager, Quality Engineering

 

Overview

As Manager, Quality Engineering he/she will perform tasks that will uphold and improve the product quality of the medical devices manufactured and meet regulatory requirements to stay in compliance.

 

Responsibilities

• Formulates and maintains quality objectives (goals) complementary to corporate policies and goals of building high quality medical devices.
• Reads and Interpret Standards in biology, chemistry, microbiology, sterilization and mechanical product testing for Standard Operating Procedures and Protocol creation supporting the manufacturing and release of Medical Devices.
• Reviews and approves the technical information within protocols and reports generated by the engineers and outside laboratories.
• Review suppliers performance by reviewing inspection (mechanical) and testing (chemistry/microbiology) results for chemicals, plastics and metal components
• Develops strategies and plans for medical device and process corrections and corrective actions with design and process improvements.
• Plays an active role in reducing costs (i.e. scrap) and increasing efficiencies within the department.
• Gathers data for the development of a departmental budget.
• Gathers QMS metrics and reports this information to the Engineers in the form of a power point presentation.
• Directly supervises 2-4 employees in the Quality Department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications

• Bachelor’s Degree in or Medical Science such as Biology, Chemistry, Pharmacy or closely related discipline
• A minimum of 6 years related experience in medical device or pharmaceutical industries.
• A minimum of 5 years related experience Quality Engineering or other Medical Device engineering functions.
• Prior People Management experience

PRECISION LIFE SCIENCES

Posted On: Tuesday, May 30, 2023