Quality & Metrology Engineer

Job Details

Job Location: fitchburg, MA

The Quality and Metrology Engineer is responsible for analyzing current processes, recommending mold and process modifications and ensuring product quality meets specified criteria. Quality Engineer helps to create solutions as part of an engineering team. The QE works to find defects, determines the causes of the defects and provides solutions to issues found.

KEY ACCOUNTABILITIES

Duties/Responsibilities:

Adhere to all company policies and to act as a role model in the adherence to policies application/interpretation and customer expectations

Provide training support in the areas of all ISO 13485 requirements, CFR 820 regulations, Micron Quality System requirements, auditing, statistical process control

Be responsible for creating Customer specific quality documentation, i.e. Control Plans, Sampling Plans, Inspection Work Instructions.

Develop and analyze production and statistical data to assure processes yield expected quality levels and to identify opportunities for improvements within the operation

Identify, develop and implement statistical sampling plans. Have working knowledge of industry standards, i.e. ANSIZ1.4

Help develop qualification/validation plans and coordinate product/process validations

Support the corrective and preventive action process by conducting root cause analysis, assisting in action plan creation, assisting in implementing of action plan as required and performing verification of its effectiveness.

Represent Micron Solutions during regular planned and unplanned interactions with customers.

The QE must be able to work within deadlines set by the external or internal customers.

Perform and document customer complaint investigations; have a strong background in CAPA investigations, including familiarity of 8-D format,

Provide support for manufacturing, project and product development activities. Review results and provide recommendations for changes/improvement

Set up inspection/metrology equipment and Incoming Inspection processes. Verify the effectiveness of quality testing and inspection activities

Monitor quality metrics and progress towards goals and objectives. Identify trends and opportunities for improvement.

Collaborate with internal process representatives to help implement quality measures and updates.

Is able to work with customers / vendors to verify specifications for an existing product as well as determine an appropriate level of variation and monitoring of quality assurance.

Provide internal and external audit support as necessary

Perform supplier audits as required to assure consistency of supplied products and work with suppliers to resolve quality issues.

JOB QUALIFICATIONS

Bachelor of Science in Engineering or related discipline or a minimum of 10 years in a Quality Assurance position required.

CQE (Certified Quality Engineer) a plus.

Expert with core competence measuring with CMM and other optical and mechanical measurement tools.

Must have 3-5 years experience with Hexagon PCDMIS

Experience with ERP software more specifically IQMS a plus.

Medical Device development and manufacturing experience.

Must have experience in the areas of metrology, auditing, and statistical analysis. ISO 13485, and CFR 820 experience preferred.

Must be able to create and execute gauge R&Rs.

Must possess computer application skills primarily MS Office. Strong facilitation and communication (written and verbal) skills required.

Validation experience preferred.

Strong organizational skills needed. Ability to work independently and strong process control background.

Experienced working in fast-paced, dynamic manufacturing environment.

PM21

PI6804cad6280c-

Full Time