안녕하세요,
저희 HR에서 올려달라고하여 게시 합니다.

혈당측정기(Medical Device) QA,QC 경험있으신분 모집하고 있습니다.
현재 Quality 직원 1명 있는데, 툭하면 Work From Home을 해서 다른 직원들에게도 영향을 주는 상황입니다.
그래서 채용하고 있습니다.
주요 업무는 제 이해로는, 저희는 한국과 베트남에서 혈당측정기,종이를 수입하고 있는데 관련한 quality audit, 품질관리 등등 업무인 것 같습니다..제가 품질쪽이 아니라 100% 업무영역은 모르지만, 저희 고객사가 5개정도라 엄청 많은 업무량은 아닌 것으로 알고 있습니다.

처우는 경력에 따라 다르겠지만 $100K 이상부터이며,
401K 6% 매치, 건강보험, PTO, 등 기본적으로 회사에 있는 것들 다 있습니다.

Position Summary: Quality Manager will ensure that all process steps needed for Risk Management are established, implemented, and maintained. Provides leadership and expertise to product development teams and tirelessly promotes quality and reliability as the cornerstone of customer requirements throughout the organization.

Responsibilities
Ability to work remotely
Manage Internal Audit program
Manage Corrective Actions, Supplier Corrective Actions
Conduct Management Reviews as required for the Quality System.
Manage the Quality interaction with and participation in the product design and development process.
Manage Document Control Process
Subject Matter Expert for Sterilization Processes. Review Sterilization data for compliance.
Review Quality Management System procedures annually for ongoing compliance.
Manage the Supplier Quality Program, including performing external surveys and audits on new and current suppliers as needed.
Manages the Material Review Board and all associated activity.
Prepares Operations organization for regulatory audits.
Manages the inspection, measurement and test equipment calibration and maintenance program.
Researches inspection equipment needed to verify product conformance, make suggestions with regard to procedures, standards and equipment to facilitate work and maintain product quality.
Directs employees involved in Receiving Inspection to assure quality control procedures are followed with regard to purchased products.
Generates Standard Operating Procedures and Work Instructions as needed.
Conducts internal and external training as required by regulatory.
Responsible for designated product release from suppliers as needed. This includes release of test strips for QC (this is through a dotted line in the Org Chart from QC to QA).
Plan and assign work as needed by leveraging both internal and external resources.

Qualifications
BS or BA in a biomedical science, engineering or medical technology.
15+ years experience in quality assurance and regulatory affairs for medical devices (familiarity with ISO 13485, CAN/CSA-ISO 13485:03 and the QSRs).
Familiarity with ISO 14971 (Medical devices — Application of risk management to medical devices).
Experience with ISO 13485 and FDA audits, international product approval processes, conducting in-depth supplier audits and managing corrective action processes.
Proven leadership skills, with 5 years supervisory and management experience and strong communication skills.