- Teleflex (Wyomissing, PA)
- …digital management tasks according to established procedures and ASTM and ISO guidelines for product/process qualification, validation, FDA submissions and legal ... and finished products in accordance with established procedures and ASTM and ISO guidelines. Such testing includes tensile and elongation, flexural modulus, moisture… more
- ThermoFisher Scientific (Millersburg, PA)
- …on experience with investigations and root cause analysis + Direct experience working with ISO 13485 or ISO 9001 and 21CFR820. + Ability to travel; ... domestic/foreign. + Preferred: prior experience in the medical device, biotech, or pharmaceutical industry. **Knowledge, Skills, Abilities** + Strong analytical, problem-solving, and teamwork skills. + Effective communication of complaints, risks, production,… more
- Philips (New Kensington, PA)
- …regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical ... Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169. + You have strong written/oral communications skills and the ability to effectively communicate with a variety of internal and external audiences (eg… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820) + Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings (FDA IDE, 510K, EU-MDR CERs, ... SSCP, PMCFs, PSURs) + Corrective Actions - Preventative Actions (CAPAs) + Health Hazard Assessment & Field Corrective Actions + Resolving product non-conformances + IMDRF dictionary terms and proficiency in adverse event coding and reportingPost market… more
- Arkema (Radnor, PA)
- …expectations + Setup, maintain and update customer master records and ISO documentation + Record and manage complaints, assign investigations, and communicate ... charges, etc. Additional activities: + Identify the need for new ISO Procedures; make recommendations for revisions. Perform other business specific related… more
- Langan Engineering, Environmental, Surveying and Landscape… (Philadelphia, PA)
- …preferred; + OSHA 500 and 501 Authorized Outreach Trainer is a plus; + Experience with ISO 14001 and ISO 45001 is a plus; + Knowledge and experience in ... industrial hygiene is a plus; + Knowledge and experience in DOT and PHMSA is a plus; + Ability to effectively manage multiple clients and projects; + Willingness and ability to identify new client opportunities is required; + Excellent written and verbal… more
- United States Steel (Clairton, PA)
- …for operations to help optimize plant performance. + Learn how to perform ISO calibrations, work with assorted databases, purchase and inventory parts in Oracle. ... Maintain and update ISO documentation, logbooks, and training materials. + The Qualified Technician will report directly to the Plant Chemical Engineer. + Perform… more
- PCI Pharma Services (Philadelphia, PA)
- …patterns requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations ... + Demonstrated expertise in quality management systems and regulatory requirements (FDA, ISO 13485, Medical Device Directive) + Strong knowledge of cGMP and other… more
- BASF (Monaca, PA)
- …and plant wastewater in support of In-Process and Finished Goods 24/7 ISO 9001 manufacturing operations. + Evaluating data versus internal and external ... (7:30-7:30)** and overtime when required **Preferred Skills** + Experience working in an ISO or GMP compliance driven lab environment + Experience working in a… more
- dsm-firmenich (Exton, PA)
- …& patent filings. + Execute the job within the applicable DSM, OSHA, EPA, ISO , FDA, CE, & other requirements. **We Bring:** + A competitive compensation package, ... Regulatory pathways associated with IDE, 510k, PMA, & CE including the associated ISO & ASTM standards. + Broad and comprehensive knowledge of engineering theories,… more