Description

Position Summary  

The Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC.  Depending on the sub-unit, Quality Specialists may work on quality improvement projects, monitor NCR’s (including associated activities), revise existing procedures, train and mentor QA personnel, manage CAL/PM systems, process change control and implementation orders, and perform specialized inspections for raw materials. This position builds upon the skills and responsibilities of a Quality Specialist and requires an increased level of self-direction and motivation. This position requires a high level of self-direction and motivation.  Timely and accurate work is expected.  This position regularly interacts and collaborates with other departments. The work is fast paced, requires prioritization of daily tasks, and attention to detail. Effective communication, written and verbal, is critical. 

Primary Duties  

Perform all work in compliance with company policy and within the guidelines of its Quality System. Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.  Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements) May present project related information to management as requested.Work cross-functionally to design new processes as needed Other Duties as assignedMinimal domestic travel may be required for training purposes 

Training and Education 

High school diploma or equivalent is requiredAssociate degree (or higher) in a life science or engineering discipline is preferred.Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required Completion of the Salt Lake Community College Medical Device Manufacturing Program or equivalent (e.g. ASQ certification; Six Sigma certification; life science or engineering related college degree). 

Experience 

Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.Minimum additional 2-year experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system. 

Knowledge, Skills, and Abilities 

Effective written and verbal communication skills.  Proficiency in MS Office tools, including Outlook, Word, and Excel. General computer operation.  Attention to detail is fundamental to this position.Ability to accurately follow written and verbal instructions.Organization skills as needed to maintain paperwork and task schedule. Proficiency in internet navigation.  Basic math proficiency.  Ability to develop and write standardized and clear instruction 

Incoming Quality 

Perform inspection of incoming materials using basic and advanced measurement toolsPerform quarantine activities including physical and electronic segregation, labeling, physical and electronic releasePerform second person verificationsInitiate NCRs with a thorough description of the nonconformance including target as well as discrepancy, quantity and standard used for rejection. Support investigation activities.Complete first article inspections.Perform and manage sorting activities to completionIdentify, initiate, and author WID updates Support and/or manage validation testing, e.g. GR&R and program validations.  Develop first draft of Technical Review  Write validation protocolsInput data into MiniTab and work with Engineering on analysis of validation data Initiate, author, and generate CO for IC documents Support/interact with Materials Management, Engineers, Purchasing, and suppliers.  This includes research activities and special projects.Perform sweeps of warehouse area to ensure cGMP compliance with a lead auditor Review co-worker completed inspection records Mentor technicians and specialistsInitiate routines and programs for metrology tools under engineer guidance; develop first draft of Tech Review Coordinate activities for metrology tool calibrationEnsure compliance to Temporary  Change Orders’s; manage expiration statusInterpret and utilize SPC chart data Analyze trends and participate in metrics development Participate as a subject matter expert in internal and external audits of the Incoming Inspection team

Physical Requirements

Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibilityMust be able to push, pull, bend, and/or lift at least 25 lbs, and may be required to lift up to 50 lbs., for extended periods of time on a daily basis.

Skills & Qualifications

Preferred specialized expertise such as IPC610 and/or IPC620 certified, GD&T background, problem solving, technical writing, black belt.Demonstrated skill set and knowledge of inspection methodologies and techniques through competency testing during the interview process. 

 

 

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).