Knowledge and application of QSR/GMP/GCP/ISO regulations as related medical devices manufacturing. The Quality Systems Manager is responsible for the management of the Abiomed's Quality System, collaborating cross functionally with various business units across multiple facilities to ensure that the Abiomed's quality system requirements are effectively established and implemented to meet all applicable regulatory requirements.

Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP.

Assures products are manufactured in compliance with regulatory requirements and manufacturing plans are monitored for compliance to ISO, GMP, and MilliporeSigma standards. Demonstrate strong quality knowledge: GMP/GDP, ISO standards.

Recording data following GMP on paper records, LIMS and SAP. 20% Support of document generation, such as material specifications, sample transport, maintenance of GMP documentation. 80% Operational support activities such as in-field sampling/inspections, sample management, records management, QC area housekeeping activities and lab support duties.

Generates and maintains the Corporate Quality Manual and Corporate Quality Procedures necessary to support compliance and certification to ISO/GMP/MDR and other related industry standards. We value your unique skills and abilities and invite you to join our team in saving lives by supplying first responders with high-tech medical products and transportation security professionals with leading-edge aviation security screening equipment.

Recording data following GMP on paper records, LIMS and SAP.Performing peer review. Performing identification testing using a RAMAN spectrometer. Sampling and labeling of chemicals/biologics in a clean room environment.

Lead continuous improvement of Quality Systems, such as CAPA, Deviation, Investigation, and Change Management, and direct the efforts to develop, implement and maintain compliant and effective Quality Systems.

Performing visual inspection and labeling of single use components such tubing, filters, and bags used in the manufacturing process. MS Office, LIMS, SAP, Trackwise, EDMS. This position is located in the raw materials warehouse.

Knowledge of regulatory requirements for medical device manufacturing, such as FDA, ISO and GMP. Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Ensure production processes are in compliance with regulatory and quality standards, such as FDA, ISO and GMP. Support the selection and qualification of suppliers and contractors to support production requirements.

Mentors quality engineers, inspectors, and other team members in all aspects of the QMS including audits, CAPA, procedure generation, and the corporate product development lifecycle process. The support of these functions also includes: Management of third party registered body contracts and planning, planning and execution of external customer and registered body audits, oversight of the Operational Documentation System, and resolution of QMS/CAPA issues.

Food Safety - Understand food safety and GMP policies at their sites and enforce those policies. Our portfolio includes creative solutions geared at helping food industry professionals compete in foodservice, retail, in-store bakery, deli, and prepared foods, among others.

Adherence to GMP, OSHA, HACCP program standards, safety, and all other plant policies. Contact: John@SourceRecruitmentSolutions.com Our client, a premier long standing consumer manufacturing company is seeking an experienced Production Supervisor for their overnight shift.

Genoskin is a Franco-American biotech company with research facilities in Toulouse, France, and Salem, MA. The company creates, develops and specializes in first-in-human data generation for drug & vaccine developers as well as cosmetic companies and academic institutions.