Sr. Manager, Quality Assurance Engineer

Mizuho OSI•Fremont, CA

9d•$172,000 - $198,000

About The Position

The Senior Manager, Quality Assurance Engineer (QAE), reporting to the Senior Director of Quality Assurance and Regulatory Affairs, supports the development efforts of Mizuho OSI’s position on medical device quality assurance and regulatory policies. This position provides guidance and leadership for the Quality Department including Quality Control Inspection, Document Control and Quality Assurance Engineering. This individual assigns and monitors the work, provides training and development to the staff and is responsible for adhering to the department’s budget. This position is also responsible for planning resources and staffing appropriately. The Senior QAE Manager provides the Senior Director feedback on department-related issues, including those with company-wide or external impact. The Senior Manager effectively participates in cross-functional teams for new product launches and supports strategic/long-term quality development and companywide compliance plans and the implementation of such policies (internal and external). The Senior QAE Manager supervises the Quality Assurance Engineering group.

Requirements

Bachelor’s degree in Engineering, Sciences or Business; MS preferred. Or related experience of five to seven years of progressively responsible Quality or manufacturing experience with at least four years in a management capacity preferred; or equivalent combination of education and experience.
Ten years of Quality experience with at least five years in a management capacity.
3-5 years of experience working with sterile medical devices. Experience in the medical device industry and manufacturing environment is required.
Knowledge of ISO and QSR requirements in the medical device industry.
Working knowledge of the listed regulations/standards is required: FDA’s 21 CFR Part 820 (Quality System Regulation), CFR Part 806 Medical Device Reporting, and 21 CFR Part 11 (Electronic Records; Electronic Signatures), ISO 13485:2016, EU MDR 2017/745 and the and other applicable regulations, ISO 14971 (Risk Management).
Ability to efficiently and effectively use Microsoft Office 365 particularly Outlook, Word, PowerPoint, Excel, and Teams
Excellent written and verbal communication skills.
Demonstrated ability to lead a technical team.
Demonstrated ability to make effective and timely decisions related to quality.
Effectively communicates both up and down the organization and maintains a customer focus.
Previous experience in conducting FDA regulated recalls or field corrections; and audits.
Excellent planning and prioritization skills with the ability to multi-task and adapt.
Ability to analyze training needs.
Experience analyzing regulations and writing procedures and developing processes and quality systems.

Nice To Haves

MS preferred

Responsibilities

Mentor, train and provide technical support to the Quality Assurance Engineering Group.
Provide frequent and timely verbal feedback to team members, as well as document their performance in the annual Focal Review performance evaluation process.
Administer and enforce company policies. Manage employee performance and assist in career development following a process to ensure fairness and proper communication as needed.
Provide guidance and leadership to the Quality Assurance Engineering group; manage resources to support schedules, priorities and customer.
Coordinate and support the internal audit program, providing quality assurance and compliance activities that are in accordance with current domestic and international requirements.
Participate in and/or manage the internal quality auditing system including planning, reporting and development of audit schedules.
Participate in and/or manages external regulatory audits/inspections including in developing corrective action plans for audit outcomes. Drives preventive actions to ensure compliance and audit ready state at all times.
Participate in and/or manage corrective and preventative action processes for both internal and external suppliers, including service providers.
Participate in Material Review Board (MRB) activities.
Participate in the development and implementation of new procedures for quality systems (ISO and QSR), consistent with Mizuho OSI policies and procedures, including local, state, federal and international regulations.
Provide direct assistance on design projects for new product introduction ensuring advanced compliance with internal and external quality requirements.
Maintain existing Quality System; generate reports of trend analysis and statistical distribution for manufacturing process audits and product audits.
Implement change and review current processes throughout the organization to enhance overall performance.
Responsible for supporting review sterilization validation processes as well as release of Sterile products
Participate as an interface and coordinator between departments to assure harmonization of Quality System documentation.
Work closely with and serve as a liaison to members of other functional teams throughout the organization, being a key resource and providing guidance and support as necessary.
Participate in Quality Systems training.
Perform other related duties as assigned.
Understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).
Understand Mizuho OSI’s business objectives and the relationship between the Department and those objectives; to support and follow the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels set by Mizuho OSI, and to continually enable Mizuho OSI to be a great place to work.