Quality Engineer

We are looking for a quality engineer.
Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements.

Key Responsibilities:
Investigate moderately complex manufacturing product quality and compliance issues (e.g. CAPA nonconformances audit observations) for all production processes prior to final product release based on engineering principles; analyze results make recommendations and develop reports.
Develop moderately complex experiments and tests (including writing and executing protocols) to create validate and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results make recommendations and develop reports.
Optimize moderately complex Manufacturing processes using engineering methods (e.g. SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for redesign/design of basic equipment tools fixtures etc. to improve manufacturing processes and reduce risk.
Develop 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.
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Other incidental duties assigned by Leadership

Additional Skills:
Good computer skills in usage of MS Office Suite
Ability to read and interpret drawings
Good documentation communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Solid understanding and knowledge of principles theories and concepts relevant to Engineering
Solid problemsolving organizational analytical and critical thinking skills
Solid 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
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment including the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) 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

Education/Experience:
Bachelors degree in engineering required.
24 years experience required.