A Black Diamond Networks client located in Massachusetts needs a sustaining quality engineer who can provide six months of contract coverage in a temp-to-permanent capacity. The engineer will serve as a team leader for quality activities including process improvements, validations, and complaint investigations. The majority of the consultant's time will be spent in a cleanroom environment. S/he will have the primary responsibility of implementing the position's key responsibilities as they apply to our client's existing products and to ensure regulatory and product performance requirements are met. Additionally, the consultant will participate in and lead the investigation of nonconformances related to complaints and CAPAs and implement robust solutions for process/device nonconformances. Finally, s/he will provide direction in implementing first article inspection, in-process sampling inspection, sampling plans, product/component testing, inspection, and acceptance criteria.
Candidates for this position should have experience with sustaining quality, CAPA, TMV, PQ, validation, medical devices, and injection molded plastic parts.