Senior Quality Engineer

Job Title

Job Overview:

Requirement/Must Have:

Bachelor's degree in engineering required.

5-7 years of experience required.

Bachelor's Degree in related Engineering/Science field (Materials Science, Mechanical Engineering, Chemistry) with 2+ years of industry experience.

Master's Degree in related Engineering/Science field (Materials Science, Mechanical Engineering, Chemistry) with 1+ years of industry experience.

Responsibilities:

Monitor Critical Control Points.

Drive the development and manage the execution of experiments and tests (including writing and executing protocols) to improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/test methods based on engineering principles; ensure completion of process validations (TMV/IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion.

Collaborate with engineers for equipment selection and validation.

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

Develop and sustain technical content of risk management files.

Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., Material Review Board, NCR, SCAR, CAPA, non-conformances, audit observations) for all production processes and based on engineering principles; analyze results, make recommendations and develop reports.

Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/technicians and operators and provides feedback; and may coordinate engineers/technician work.

Lead, review and approve compliant change control.

Nice to Have:

ASQ Certified Quality Engineer (CQE).

Six Sigma Green Belt or better.

Skills:

Proven expertise in usage of MS Office Suite.

Ability to read and interpret drawings.

Proven expertise in statistical techniques.

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

Ability to translate technical information to all levels of the organizations.

Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge).

Knowledge of Six Sigma concepts with ability to apply to work product.

Knowledge of Quality Engineering concepts with ability to apply to work product.

Problem-solving, organizational, analytical and critical thinking skills.

Understanding of processes and equipment used in assigned work.

Strong leadership skills and ability to influence change.

Knowledge of and adherence to the Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.

Strict attention to detail.

Ability to interact professionally with all organizational levels.

Ability to manage competing priorities in a fast-paced environment.

Work is performed independently.

Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts.

Experience with automation, software testing, and software validation is strongly preferred.