To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03517

About our client Our client is a global medical device firm headquartered in North Carolina that specializes in invitro diagnostic kits focused on infectious diseases. The organization has an experienced management team, a robust pipeline of products, a world-class corporate culture and an established reputation for being a leading innovator in the field. Position Location Manager Quality Assurance and Quality Control Portland, OR Salary Highly competitive package, commensurate with experience Responsibilities 1) Serve as the Management Representative for the manufacturing facility and lead assessments of the quality systems for compliance (eg. customer, FDA, ISO Registar), and ensure that such assessments are conducted in accordance with established policies and procedures to maximize their benefit in the company. 2) Responsible for the execution of the Quality System Management Review process to determine the effectiveness of the site quality system. 3) Responsible for the development, maintenance and implementation of the Complaint Investigation, CAPA, and Audit Processes. 4) Ensure all activities of the Quality Control departments are executed in a timely manner including inspection, laboratory testing, document review, lot release, environmental monitoring and product stability program. 5) Recruit and develop employees who will function well within the company’s corporate culture. 6) Evaluate and direct employees to ensure job satisfaction and improvement. 7) Encourage staff to take initiatives, to be proactive, and to strive to improve their work and the processes that shape their work. 8) Identify the key personnel needed to address opportunities, establish resources appropriate to the projects, and determine actions that will be followed to accomplish the established objectives. 9) Lead or facilitate teams to accomplish the deliverables, milestones, and objectives meeting the plans and schedules ensuring that any changes to the plans are communicated and agreed to by the teams and project sponsors. 10) Develop and implement Quality and compliance training programs that provide necessary organizational knowledge to achieve company and regulatory objectives including compliance. 11) Establish, maintain and improve reports of quality data such as customer satisfaction, business level quality, and functional area quality indicators to assist the continuous improvement of quality and analyze them to assess the effectiveness of both the company quality system. This data is included in regular reports to senior executives for the Quality System Management Reviews. Requirements 1) Bachelor’s degree with 10+ years experience or equivalent experience in related industry. 2) Masters Degree preferred 3) Minimum 5 years managerial experience. 4) Ability to effectively communicate written or orally. 5) Experience in directly managing regulatory audits by FDA and ISO. Competence in the selection and use of Quality Engineering Tools and Techniques. 6) Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (eg. ISO, QSR, UL, CSA, VDE, etc.). 7) Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Biomedical Advisor (CBA), Certified Manager of Quality (CMQ) or Six Sigma Black Belt desired.