Sr. Manager Quality Assurance Engineer

Sr. Manager Quality Assurance Engineer Mizuho

OSI - 3.1

Union City, CA Job Details Full-time $172,000 - $198,000 a year 1 hour ago Qualifications Microsoft Excel Microsoft Outlook ISO standards Writing skills Compliance audits & assessments Policy & process development Continuous improvement Team management Attention to detail Task prioritization Decision making Microsoft Teams Quality audits Manufacturing Manufacturing company experience Cross-functional communication FDA regulations Full Job Description Job Summary 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.

Qualifications & 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.
• This is a must have 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.

Pay:

$172,000.00 - $198,000.00 per year

Work Location:

In person