Quality Control Associate

Roche•Marana, AZ

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position At Roche Tissue Diagnostics, we have revolutionized cancer diagnostics worldwide through state-of-the-art testing automation. We provide more than 250 cancer tests and associated instruments, making us the leading global supplier of cancer diagnostic systems to the pathology market. Through excellence and innovation in science and engineering, our people are leading the discovery, development and delivery of diagnostic systems and tissue-based cancer tests that are guiding the future of healthcare. This culture of constant innovation at Roche Tissue Diagnostics fuels our vision: to empower our customers by providing the highest quality, most innovative cancer diagnostic solutions. We are passionate in our pursuit of diagnostic solutions that improve the practice of medicine because when we empower pathology professionals, we brighten the outlook for patients. Relocation benefits are not available for this job posting. The opportunity: Inspects incoming materials using precision measuring instruments and electronic testing equipment to determine conformance to written specifications. Reviews material specifications, receiving inspection instructions, supplier quality history records. Inspects and measures material for conformance to specifications in Lab and Supplier facilities as scheduled by the Group/Team Leader or when requested. When non-conforming material is discovered will be responsible for informing the Supplier Quality Engineer and initiates Non-Conforming Reports (NCRs) and follows up as appropriate. When non-conforming material is discovered will be responsible for informing the Supplier Quality Controls the release of in-coming materials and non-conforming materials discovered after release. Assure compliance with quality system requirements as it applies to the outputs of this defined job specifications. Maintain metrics and communicates issues or potential problems to appropriate personnel. Records inspection results on inspection records. CMM programming preferred. Complies with prioritization of work schedule as established by Group/Team Leader. Works in accordance with applicable FDA, IVDD and ISO regulations and standards. Participates in design reviews as required. Demonstrates attention to detail. Work schedule may include evenings and weekends. Monitors work to ensure quality, and continuously promote Quality First Time. • Acquire and provide training as needed. Participates with IQC team on daily MDI and 5S activities. Participate in continuous improvement programs and kaizens. May perform other duties as required or assigned by team lead or manager. Other duties as assigned by management.

Requirements

Minimum Qualifications: Associate's Degree in in a technical field.
American Society for Quality (ASQ) or equivalent Certified Technician (preferred)
Minimum 3 years of experience in precision mechanical and/or electrical components inspection.
Familiarity with Quality System including ISO.
Experienced with standard measurement tools such as calipers, micrometers, gage blocks, optical comparator, and Coordinate Measuring Machine (CMM).
Independently interpret and follow engineering specifications drawing experience.
Able to do CMM programming (preferred)
Experienced interfacing with Business Enterprise System such as SAP (preferred)
Ability to read, analyze and interpret drawings and schematics, professional journals, technical procedures, or governmental regulations.
Able to communicate results of inspections to peers and supervisors verbally and in writing.
Ability to work with mathematical concepts such as probability and statistical inference with the ability to apply concepts such as fractions, percentages, ratios, and proportions.
Ability to solve practical problems and deal with a variety of variables.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to interpret and work in accordance to Ventana quality system QPs and manufacturing OPs pertaining to this position.
Computer Skills: Excel Spreadsheets, Word processing, E-mail, Measuring equipment software.

Nice To Haves

American Society for Quality (ASQ) or equivalent Certified Technician (preferred)
Able to do CMM programming (preferred)
Experienced interfacing with Business Enterprise System such as SAP (preferred)

Responsibilities

Inspects incoming materials using precision measuring instruments and electronic testing equipment to determine conformance to written specifications.
Reviews material specifications, receiving inspection instructions, supplier quality history records.
Inspects and measures material for conformance to specifications in Lab and Supplier facilities as scheduled by the Group/Team Leader or when requested.
When non-conforming material is discovered will be responsible for informing the Supplier Quality Engineer and initiates Non-Conforming Reports (NCRs) and follows up as appropriate.
When non-conforming material is discovered will be responsible for informing the Supplier Quality Controls the release of in-coming materials and non-conforming materials discovered after release.
Assure compliance with quality system requirements as it applies to the outputs of this defined job specifications.
Maintain metrics and communicates issues or potential problems to appropriate personnel.
Records inspection results on inspection records.
Complies with prioritization of work schedule as established by Group/Team Leader.
Works in accordance with applicable FDA, IVDD and ISO regulations and standards.
Participates in design reviews as required.
Demonstrates attention to detail.
Monitors work to ensure quality, and continuously promote Quality First Time.
Acquire and provide training as needed.
Participates with IQC team on daily MDI and 5S activities.
Participate in continuous improvement programs and kaizens.
May perform other duties as required or assigned by team lead or manager.
Other duties as assigned by management.