Quality Engineering Manager

SCIENTIA VASCULAR INC

10d

About The Position

This position will work in all aspects of the Scientia Vascular Quality System related to quality engineering related to manufacturing and operations. This position will work closely with all other departments to develop, implement, and monitor quality systems to deliver quality product to customers while maintaining regulatory compliance. This position will work under general direction and have latitude in determining how to solve problems.

Requirements

BA/BS degree in a Life Science, Engineering, Physical Science, a related field of study or equivalent work experience and/or professional qualifications.
At least 5 years in the medical device industry, with both progressive leadership experience and “hands-on” in manufacturing and quality systems development for quality control (incoming, in process, and final product release), nonconformance, process and equipment qualification for on market products and design transfer of new product introductions.
Strong leadership ability, coupled with superior interpersonal, communication and influencing skills.
Knowledge and experience with quality systems, concepts, regulatory compliance requirements and applied statistical concepts.
Demonstrated knowledge of interpretation and application of cGMP, QSR, MDD, ISO 13485, ISO 14971 and other international standards.
Ability to make sound decisions under pressure with reasonable foresight as to outcomes.
Demonstrated expertise in interpretation and pragmatic application of Quality standards.

Responsibilities

Overseeing all aspects for quality control activities (incoming, in process, and final product release), nonconformance handling, both process and equipment qualification of existing products and quality support for design transfer of new product introductions.
Work closely with Manufacturing, Operations, and Research and Development personnel during internal nonconformance and external complaint, processing, investigation, and closure.
Support new supplier and component qualification, and ongoing supplier surveillance activities.
Support the issue escalation process as an input into the field action and recall process.
Develop and monitor manufacturing quality data and metrics.
Performs all activities in manufacturing quality engineering with a focus on prevention, continuous improvement, and customer satisfaction in regulated environment.
Ensures the company is in a constant state of readiness for audits such as FDA, ISO, and Scientia customers.
Coaches, mentors and trains Quality Control and Manufacturing Quality Engineering team.
This position has the necessary independence, authority, and responsibility to initiate action to prevent nonconformities, enact remediation plans, and proactively identify and document potential nonconformance issues.
Additional duties and responsibilities as assigned