QA/QC Admin SpecialistApply Job ID REF3775Z Date posted 09/28/2021 Address 209 Creekside Drive, Washington, NC Job Type Full-time Job Status Non-Exempt
Founded in 1912, Illinois Tool Works Inc. (NYSE: ITW) is a diversified, Fortune 200 manufacturing company that delivers specialized expertise, innovative thinking and value-added products to meet critical customer needs in a variety of industries. Ranked among Fortune’s Magazine’s most admired companies, the company focuses on solid growth, improving profitability and strong returns across its worldwide platforms and divisions. These divisions serve customers and markets around the globe, with a significant presence in developed as well as emerging markets. ITW’s revenues totaled $14.1 billion in 2019.
ITW Medical is comprised of three highly-respected medical product brands - Coeur, Filtertek & Precise Biomedical – supplying medical devices, components and service to global medical device brands. Filtertek manufactures molded filtration and flow control components. Precise provides technical service, maintenance & training for contrast media injectors. Coeur is a leading provider of disposable diagnostic imaging consumables.
This position will report to ITW Medical’s Quality Manager. The individual will be responsible for support of day-to-day Quality System Management functions for the ITW Medical, Washington site. The successful Quality Assurance/Quality Control Analyst will be a for a self-starter interested in learning Quality aspects of the medical device business.
DUTIES AND RESPONSIBIITIES:
· Provide support and backup/backfill for all tasks and duties associated with Label printing and control, documentation files
· Provide Quality support to customers and production primarily in the final release of product and management of Device History Records
· Protect the quality of produced parts in all related discussions and decisions
· Release Finished Goods for Sale
- Review and approve sterilization records and lab test results for product release
- Prepare Certificate of Conformance (CoC’s) for all Finished Goods
- Release of Non-Sterile product after Production job is closed and DHR reviewed
- Release of Sterile product after Sterilization process
- Complete time-sensitive releases to meet critical shipment schedules
- Experience in understanding regulatory matters, the need to comply and the ramifications of decisions regarding product releases
· Create sterile load documents for shipping
· Device History Record management
- Assemble necessary documentation for DHR’s for all products produced
- Add release and CoC documentation to DHR’s
- Maintain physical documentation and records files
· Support Quality Investigations by completing thorough DHR reviews
· Manage LAL sample submissions for testing
- Ensure LAL samples are packaged correctly
- Send LAL samples to approved lab for analysis
- Track LAL results timing
- Submit expedited testing requests to management as needed to meet release schedule
· Maintain Customer CoC templates for RexMed
· Primary liaison for Sterilizer, contract lab and warehouse
· Generate reports, charts and graphs as needed to communicate status and identify potential areas for improvement or cost savings
· Support other members of department/plant as needed and at Management discretion
- Document and Record Coordination
- Create and update documentation through change management
- Coordinate reviews and approvals
- Update Document Control internal system with correct revisions
- Manage Revisions/Revision Communication with Manufacturing Locations
- Support in Quality Management System
- Corrective / Preventive / Continuous Improvement Actions
- Deviations/Rework Instructions
- Customer Feedbacks
- Associates Degree is preferred
- Minimum of 1-2 years of relevant experience; preferably in Medical Device Industry
· Ability to read blueprints and/or technical experience is preferred
- Ability to understand financial impact of decisions, including knowledge of expenses and budgeting
- Demonstrated ability to conduct research, identify/evaluate opportunities, and develop strategy for addressing compliance opportunities
· Product development experience is a plus.
- Ability to work directly, and through teammates, to implement plans and strategies
- Must be able to foster, communicate and exemplify the values of ITW; act with integrity and trust, operate with simplicity, treat everyone with respect, take shared risk.
- Adapt and flourish in the changing regulatory environment and circumstances
· Proficient computer skills - MS Office (PowerPoint, Excel, Word, Outlook, etc.)
· Must be a team player with excellent interpersonal and relationship building skills
· Excellent verbal, written, interpersonal, communication and presentation skills with experience in communicating and working with a remote team.
· Proven time management, prioritization abilities and demonstrated strong project management skills.
· Must possess decision making skills necessary to flourish in a complex regulatory environment.
· Must be able to travel domestic and/or international, up to once per month.
· Takes initiative; able to function independently and make independent decisions
· Proven thought leadership capabilities, innovative thinking skill set and the ability to drive change
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· This position requires some physical movement around the machine areas. This position requires an operator to stand for 90% of their work shift with two scheduled breaks and a 20 minute lunch.
· Some lifting of boxes or totes may be required intermittently.
· While performing the duties of this job, the employee is regularly required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is frequently required to reach with hands and arms, stoop, kneel, or crawl; and talk or hear.
· The employee must frequently lift and move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
ITW offers a competitive compensation and benefits package, including competitively priced medical and dental coverage the first of the month following hire, free life insurance, paid vacation and holidays, and immediate 401k matching. Additional retirement savings contribution (above and beyond 401k) is awarded at no cost after one year.
ITW Medical is an equal opportunity, equal employment, affirmative action employer. We strive to create a diverse and inclusive work environment where everyone is welcome to contribute their unique talents and ideas. We encourage applications from females, males, disabled/protected or other veterans, persons with disabilities, all races and ethnicities, sexual orientations and gender identities. Reasonable accommodation will be made to enable persons with disabilities to apply and to perform the essential job functions. If you require assistance with completing an application, please reply that you require assistance.
All your information will be kept confidential according to EEO guidelines.
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