Job Description

Job Title: Cybersecurity & Quality – Medical device Duration: 12+ months Location: Temecula, CA W2 hourly rate: $ • Prepares overall project quality plans including milestones, validation processes and documentation procedures. • Conducts special analyses and projects as required. • Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence. • Responsible for problem resolution, communication and policy implementation. • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements. • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • Performs other related duties and responsibilities, on occasion, as assigned. Qualifications: General Qualifications • A Bachelor's degree in an applicable engineering discipline with ten (10) plus years of progressively more responsible work experience in quality assurance and design related to medical devices, preferably in electro-mechanical and implantable medical devices (class III and IV). • Broad cross-disciplinary and in-depth knowledge and experience with industry accepted quality assurance design methodologies and project management tools. • Direct cybersecurity and product development experience. • Five years or more in quality or R&D engineering management. • Desired: An advanced credential in a relevant discipline/concentration. Professional certification or designation, such as CQE, CSQE, CRE and/or CMQ/OE. • Ability to work in a highly matrixed and geographically diverse business environment. • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. • Ability to work effectively within a team in a fast-paced changing environment. • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. • Multi-tasks, prioritizes and meets deadlines in timely manner. • Strong organizational, planning, and follow-up skills and ability to hold others accountable. • Ability to maintain regular and predictable attendance.

Company Description

Asen has been in business since 1975 and we are 1st tier preferred vendors for our MSP,VMS clients. Fortune 500 companies. We stay in the top 5 on most recent report cards for IT,Clinical, Creative and Engineering. Our recruiters are well trained and long time employees who love to pick up the phone and talk to you. Bringing our business back to personal to get the best candidates for the positions we are looking to fill. We are a certified woman owned company with government security clearance. We are an equal opportunity employer.