Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Quality Control Engineer- Computer Systems Validation

Expired Job

S.Com Franksville , WI 53126

Posted 2 months ago

Quality Engineer- Computer Systems Validation
Quality Engineer with computer systems validation experience in the Medical Device, BioTech, and/or Pharmaceutical industry is needed to participate in support activities involving regulatory compliance. This is a long term contract position budgeted for at least a year .

Responsibilities for the Quality Engineer-Validation
Responsible for executing computer systems validation.
Participate in and support activities involving compliance with applicable regulatory and Quality Management System requirements.

Requirements for the Quality Engineer- Validation Engineer
BS in Science or Engineering with at least 3+ years experience in Computer Systems Validation in accordance with 21CFR Part 11 and GAMP 5
Required Experience in Medical Device and/ or Pharmaceutical industry.
Strong technical writing and general problem-solving skills required.

Employer will not sponsor applicants for work visas for this position.
Please apply online or email . If you dont meet these requirements, but are interested in other Impellam NA, Corestaff Services or s.com opportunities, please register with us online at ess.impellam.com
scom is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

Skills:
Computer Systems Validation
Contract
Long Term


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Quality Engineer

Merz Pharmaceuticals USA

Posted 3 months ago

VIEW JOBS 9/19/2018 12:00:00 AM 2018-12-18T00:00 This position is responsible for providing engineering and technical support to the Quality Department. This position would support a wide array of activities related to Software Quality, Change Control, NCR/CAPA, Product Surveillance, New Markets and Risk Management. This position would be the lead quality support for design control activities. This position would evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. Provide direct support to Quality personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed. Major duties * Software Quality -Originate, review, and approve Software Quality Systems processes and operating controls in accordance with global industry standards, regulations, and requirements (Design, Risk, Validation, CAPA, etc.). * Change Control activities -Originate, review, and approve internal operating procedures and specifications through the Document Change process * Support NCR and CAPA activities -Corrective/Preventive actions and product non-conformance control including: capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting. * Support Product Surveillance activities -Support Product Surveillance through review and ownership of data/trend evaluations and investigations associated with product and patient complaints, analyzing the data for the reasons of Quality Improvement and reporting. * Support New Markets activities -Support New Markets activities including: management of new markets samples process, coordination between new markets group in Germany and WI Tech Ops to manufacture samples, filing of applicable new markets documentation in the Design History File (DHF) * Support Risk Management activities - Lead Risk Management activities including: data preparation for annual product risk file review, review internal documents (IFU, CER, etc) for annual product risk file review, management and preparation of event-based reviews, review and coordination of quality activities related to pFMEA risk matrices. * Supports Internal and Vendor Audit Functions -Supports Internal and Vendor Audit Functions as needed. * R&D Support -Be the lead quality team member to R&D department in the development and validation of new products. * Process improvement initiatives -Coordinates process improvement initiatives for the Quality Department * Adherence to regulations -Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices. * Other duties as assigned- Provides support to Quality Management personnel and perform other duties as assigned. Education- * BS in a Physical Science or Engineering, or equivalent experience required. Required * ASQ Certification as a Quality Engineer or equivalent. Preferred * BS Engineering -Preferred Professional experience * Experience with electro mechanical device software and hardware validation. Required Knowledge, skills and abilities (incl. languages) * Knowledge of regulatory requirements for medical device / pharmaceutical organization. Required * Strong technical and general problem-solving skills required; experience with NCR/CAPA processes. Required * Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; and Quality System Management Software. Required * Experience in performing internal and/or supplier audits. Preferred Knowledge of methods * Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations. Required * Understanding of IEC 62304. Required * Understanding of system software, firmware, and hardware integration. Required * Medical Device Risk Management regulation ISO 14971 . Preferred Personal skills * Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization. Required * Manage multiple priorities and work with interruptions. Required * Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required. Required Merz Pharmaceuticals USA Franksville WI

Quality Control Engineer- Computer Systems Validation

Expired Job

S.Com