Quality Engineer

Looking for a Quality Engineer to be akey member of a cross-functional core team in the medical device industry.

Job Responsibilities:

Leads investigation of manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.

Identify and ensure the optimization of Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.

Update, and maintain technical content of risk management files.

Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.

Collaborates with R&D, NPD, Pilot, Manufacturing, Operations, and personnel at other facilities.

Skills:

Proven expertise in usage of MS Office Suite.

Medical device industry experience required.

Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.

Working knowledge and understanding of statistical techniques.

Previous experience working with lab/industrial equipment required.

Strong problem-solving, organizational, analytical and critical thinking skills.

Substantial understanding of processes and equipment used in assigned work.

Knowledge of and adherence to Quality systems.

Strict attention to detail.

Ability to interact professionally with all organizational levels and across sites.

Ability to manage competing priorities in a fast paced environment.

Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.

Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.

Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Strong understanding of applicable FDA regulations and ISO13485 for medical device industry.

Education/Experience:

Bachelor's Degree or equivalent in in Engineering or related field, minimum 2 years related industry experience required or

Master's Degree or equivalent in in Engineering or related field, minimum 1 year experience related industry experience required.