Quality Engineer

Quality Engineer page is loaded
** Quality Engineer
** locations

San Marcos, CA    time type

Full time    posted on Posted Today    job requisition idJR
100660    
** By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
** Pay Range:$73,100.00 - $Responsible for supporting Quality Engineering requirements for new product development, legacy product maintenance activities, continuous improvement, risk management and customer satisfaction. Will serve as a subject matter expert and liaison between company and customers/vendors with the goal of resolving quality and manufacturing issues and ensuring positive channels of communication to ensure customer satisfaction.

Duties and Responsibilities:

· Key member of complaint and MRB investigation teams. Analyze, identify, develop and implement manufacturing, production, and other process improvements which will improve capability, and/or performance. Meet with appropriate teams and/or individuals to offer recommendations and share results.
· Create Failure Mode and Effects Analysis (FMEA) for new and existing products based onrisk assessment and in alignment with ISO 14971:2019. Collaborate with R&D and Regulatory department personnel to align risks identified and mitigations to reduce and control risk.
· Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment validations performed by other departments.
· Represent the company via interactions with Suppliers including new products, Supplier Corrective Action Reports, change notifications, etc. Review SCARs sent back from suppliers to assess corrective actions. Conduct and/or participate in supplier audits.
· Represent Quality on new product development teams and transition new designs into production. Work closely with Operations personnel to develop strategy and plans for implementation.
· Schedule and lead periodic cross-functional meetings to review the Validation Program.

Recommend process/equipment candidates for re-validation based on changes to operations, processes and practices. Write, review, and approve validations, when necessary, (installation qualification IQ/operational qualification, OQ/performance qualification PQ protocols, Standard Operating Procedures (SOP), technical reports, andfinal reports) for new products, processes, and equipment; ensure systems, utilities, and processes comply with the Food and Drug Administration (FDA) and industry standards.
· Participate in management review meetings and/or prepare information and trending data tobe shared in the meeting.
· Enable positive communication channels internally and externally to ensure the highest levelof customer satisfaction.
· Develop, prepare, and implement Quality Program plans for new and existing customers specific to validation and qualification activities.
· Author new or revised SOPs per the QMS while ensuring consistency of processes, verbiage and taking into consideration personnel in each functional area. Act as a signatory in Change Control when necessary.
· Actively participate in internal, customer, and third-party audits.
· Other duties as assigned.

Knowledge, Skills and Abilities Required:

· Manage time wisely and effectively prioritize multiple competing tasks.
· Ability to identify and solve problems, develop innovate solutions, act decisively and applygood judgement.
· Readily able to offer opinions and take action when the position may be unpopular.
· Skilled at handling situations diplomatically.
· Proven team player who has demonstrated capabilities in the following areas: excellent communication, interpersonal skills, well developed problem-solving skills; solid organizational skills and the demonstrated ability to be self-directed and effectively relate toall levels of the organization.
· Strong computer skills a must, to include Word, Excel, PowerPoint; experience with Access Database is a plus.

Minimum

Job Requirements:

Bachelor of Science…