- Caris Life Sciences (Irving, TX)
- …in accordance with internal SOPs, Quality System Requirements which include ISO 13485, FDA QSR , IVDR, SOX, SOC2, and IEC 62304 + Reviews and approves various Design ... Process and applicable Software Validation Planning documents in alignment with FDA QSR , 21 CFR Part 11, and GAMP5 regulation requirements. + Collaborates with… more
- Cordis (Miami Lakes, FL)
- …technical and uniquely collaborative. **Responsibilities** Coach and Influence + Lead supplier development efforts with empathy and authority-mentoring suppliers ... organized and stakeholders aligned. Capability Analysis & Data-Driven Insights + Lead data sampling and capability studies to identify opportunities for improvement,… more
- Teleflex (Pleasanton, CA)
- …specifications. - Design prototypes and feasibility models for proof-of-concept testing. - Lead the DOE and reliability effort for the project. - Develop new ... operators to ensure manufacturability of the new design. - Lead overall design efforts, including design/process characterization, verification, and validation… more
- Kerry (Beloit, WI)
- …About the role We are seeking a dynamic and experienced Director of R&D to lead our Stocks and Broths platform in North America. This role will drive innovation, ... leadership, and product development across customer segments including retail, QSR , foodservice, and industrial manufacturing. The Director will be responsible… more
- Integra LifeSciences (Mansfield, MA)
- …collaboration with cross functional teams. This role is responsible to also lead and coordinate process, practice, procedures and technology adoption for the ... assessments in risk management to support continuous improvement across business processes Lead the process of planning, organizing, leading and reporting all risk… more
- Teleflex (Chelmsford, MA)
- …metrics, such as yield, efficiency, etc. are met and sustained. - Lead investigations tied to Non-Conformances, Complaints, and CAPA. Produce as team member ... team as required for leadership or engineering technical assistance. - Lead engineering actions identified though production visual management boards - Source,… more
- Cordis (Irvine, CA)
- …and report overall team/shift performance in key metrics. You will also lead and manage manufacturing teammates and coordinate with other stakeholders to ensure ... CAPA (Corrective Action, Preventative Action) + Champion cGMP and QSR concepts and procedures + Champion 5S and Lean...procedures + Champion 5S and Lean Manufacturing principles + Lead and manage projects (as assigned). Develop resources to… more
- GRAIL (Durham, NC)
- …820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards. + Lead regularly scheduled meetings to ensure timely and compliant completion of ... training and competency programs for the CAPA and NCR processes. + Lead software system configuration maintenance and improvements, including testing and validation,… more
- Teleflex (Plymouth, MN)
- …responsibility for completeness and accuracy of developed processes (ie, lead , manage, communicate, complete documentation, train) including ownership of process ... Maintain knowledge of new developments in manufacturing and design technologies. - May lead or serve as member on cross-functional project teams. - Maintain positive… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and SME for Initiatives and Queries from leadership, other disciplines. + Direct and lead multiple HFE projects or phases at any one given time leading the design ... for Industry and Food and Drug Administration Staff', Quality System Regulation ( QSR ), ISO 13485, 14971, EN 60601, Council Directive 93/42/EEC, 62366. HE 75,… more
- Cordis (Miami Lakes, FL)
- …and multi-lumen tubing, thin-wall profiles, co-extrusions, and balloon films. + Lead process validation (IQ/OQ/PQ) activities, ensuring compliance with ISO 13485 and ... FDA QSR requirements. + Troubleshoot and resolve extrusion process issues,...compliance to ISO 13485 and FDA 21 CFR Part 11/ QSR . + Proficiency with statistical analysis tools and process… more
- Battelle Memorial Institute (Columbus, OH)
- …with the program manager as both an individual contributor and or a technical lead responsible for guiding other engineers also depending on the needs of the ... plastic part experience + Understanding of the FDA Quality System Regulation ( QSR ) and involvement in an ISO13485 operational environment **Travel Requirements:** up… more
- Gpm Investments LLC (Wise, VA)
- Overview The QSR Team Leader greets and serves guests, prepares food, maintains food safety and sanitation standards, and handles or processes light paperwork. The ... Team Leader also assists in training of new employees and some ordering. Exceptional customer service is a major component of this job. Pay Rate: $12.41 Open Availability All Shifts Responsibilities + Exhibits a cheerful and helpful manner while greeting… more
- OTG (Newark, NJ)
- …YOUR NEXT OPPORTUNITY IS NOW BOARDING Join OTG as a Starbucks(R) Daily Operations Lead now at [EWR] and drive a new type of travel hospitality experience. Discover ... You drive it. ROLE AND RESPONSIBILITIES As an OTG Starbucks(R) Daily Operations Lead at [Airport name], you will support the store manager in executing daily… more
- TravelCenters of America (Portage, WI)
- …who sets the example when working alongside team members + The ability to lead , motivate, train and develop people to unleash the talent within each team member ... + High School Diploma (or GED) required. Associate's or bachelor's degree preferred + 3+ years of supervisory experience in the fast-food industry preferred + Proficient planning and analytical skills (ie understanding the calculations on the P&L, coverage… more
- TravelCenters of America (Moriarty, NM)
- …who sets the example when working alongside team members + The ability to lead , motivate, train and develop people to unleash the talent within each team member ... + High School Diploma (or GED) required + Supervisory experience in the fast-food industry preferred + Exhibit good verbal and written communication skills + Ability to work flexible hours including nights, weekends and some holidays + Proficient in Microsoft… more
- Actalent (Brooklyn Park, MN)
- …independently and on a multi-disciplinary team + Good understanding of ISO 13485 and FDA QSR + ISO 13485 Lead Auditor training and certification Job Type & ... + Drive accurate and repeatable Test Method and Inspection methods development, Lead Test Method and Inspection method validation; analyze data and prepare test… more
- Abbott (Alameda, CA)
- …career as you help Abbott shape the future of healthcare. This **Nonproduct SWQA Lead ** is responsible for ensuring that computerized systems used in the support of ... support of implementation and maintenance of the nonproduct software lifecycles. + Lead , oversee or contribute to multiple portions of the Quality System, including… more
- Takeda Pharmaceuticals (Round Lake Beach, IL)
- …the best of my knowledge. **Job Description** **About the role:** The Lead Investigator will initiate and execute deviations in support of Manufacturing. ... through application of the problem-solving tools and methods to coordinate and/or lead investigation teams. Lead routine and complex investigations. + Actively… more
- HRPivot (Tucson, AZ)
- …development, design architecture, and product lifecycle management in compliance with FDA QSR , ISO 13485, and applicable standards. + Lead planning, execution, ... technologies. Position Summary: The Director of Research & Development will lead the design, development, and advancement of innovative Class III medical… more
