Quality Engineer, Associate

Position: QUALITY ENGINEER, ASSOCIATE
POSITION SUMMARY:

Apply engineering/technical skills and 6 sigma and/or lean manufacturing methodologies to make recommendations and carry out Quality improvements with the Design, Manufacturing and Quality of the products and services offered to customers. Perform product validations, process validations and equipment qualifications to maintain FDA compliance as applicable.

PRINCIPAL JOB

DUTIES & RESPONSIBILITIES:

Develop procedures and perform other tasks typical of the Quality Engineering position, such as but not limited to, writing quality plans, assisting the inspection team with technical or procedural guidance, investigate RCA as needed when problems arise and assist in implementing CAPA, with both suppliers and customers on an as needed basis. Carry out process validations, equipment qualifications and assist with material certification as necessary from the suppliers.

Perform as an active member of product design and development teams assisting in product qualification and validations.

Provide support to Manufacturing in customary Quality Engineering roles, as well as provide support to other Quality team members (Inspectors etc.) as needed.

Execute and administer CAPA (Corrective and Preventive Action) tools as required, both internally and externally to bring about the desired positive changes and continuous improvements.

Define/maintain Quality metrics for internal and external reporting. Perform trend analysis as required.

Review Design History Files for accuracy and compliance to internal and FDA requirements.

Revise Quality System and Manufacturing procedures as required.

Represent Quality on various teams, including ISO or FDA Audits providing data analysis as needed.

Write and submit NCMR’s and create Deviations or initiate and participate in control of non-conforming materials

Participate on Internal Quality Audit Team.

Visit and audit suppliers as necessary from time to time.

REQUIRED SKILLS, KNOWLEDGE, AND

EXPERIENCE:

Bachelor’s degree in engineering required. Mechanical, Manufacturing, Process or Quality Engineering Degree a plus.

Strong working knowledge of computer database systems, Microsoft applications, PC, and various software programs required.

Strong aptitude for problem solving, root cause analyses, and an understanding of dynamic mechanical assemblies desired. Process/product validation experience a plus.

Must have working knowledge of ISO 13485, FDA, QSR, GMP’s and QSIT.

Experience with Quality Risk Assessment tools such as HARMs, FMEA, MRB, CAPA, required.

Good written and oral communication skills a must.

Capable to present data (presentations) to management teams and train co-workers as needed.

Must have ability to properly interpret Engineering drawings and clearly present that information to others.

Ability to travel to other facilities to support quality audits and/or issues is required.

Able to frequently multi-task and assist QA Manager or others in QA with their job-related dutiesASQ Certification as a CQE, or any related ASQ certification (past or present) is strongly desired.

COMPETENCIES:

Analytical Thinking – Approaching a problem by using a logical, systematic, sequential approach.

Forward Thinking – Anticipating the implications and consequences of situations and taking appropriate action to be prepared for possible contingencies.

Diagnostic Information Gathering – Identifying the information needed to clarify a situation, seeking that information from appropriate sources, and using skillful questioning to draw out the information.

Providing Motivational Support – Enhancing others’ commitment to their work.

Fostering Teamwork – As a team member, the ability and desire to work cooperatively with others on a team; as a team leader, interest, skill, and success in getting groups to learn to work together cooperatively.

Self Confidence – Faith in one’s own ideas and ability to be successful; taking an independent position in the face of opposition.

Personal Credibility – Demonstrated concern that one be perceived as responsible, reliable, and trustworthy.

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an associate to…