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...

Assists the local PV Manager (LPVM) for Global Patient Safety (GPS) · Support and attend affiliate/GPS meetings to ensure awareness of any changes in global and/or regional requirements of the PV system · Provides Pharmacovigilance expertise into all areas of the business as required. · Ensure a comprehensive local PV system · Ensure all PV activities are delivered in line with local...

Sr. Specialist, Quality Assurance - Internal Audit   Overview As Sr. Specialist, Quality Assurance, he/she will perform task that will uphold and improve the product quality of medical devices manufactured and meet regulatory requirement to stay in compliance.   Responsibilities • Executes day to day activities based on quality objectives (goals) complementary to corporate policies and...

Quality Engineer   Qualifications: Bachelor’s degree in Engineering discipline or equivalent. Up to three years of related experience and/or training; preferably in the medical device industry related to process/quality engineering. Knowledge of basic mechanical testing and material properties. Knowledge of metrology. Familiar with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO...

Quality /Regulatory Manager   Job Position Summary: The Quality /Regulatory Manager shall be responsible for “hands-on” oversight and continued implementation of the Company’s existing Quality Management System (QMS) certified to ISO 13485:2016 and meeting the MDSAP regulatory requirements for the US and Canada and certification to ISO 9001:2015. The Quality /Regulatory Manager shall directly...