Sr. Manager, Quality Assurance Engineer

Mizuhosi; Union City (CA); On-site; USD 172,000 - 198,000; Full time

Benefits offered by this job

Annual bonus

Comprehensive benefits package

Job summary

Mizuho OSI is seeking a Senior Manager, Quality Assurance Engineer to lead the QA Engineering group and ensure compliance with regulatory requirements. This role reports to the Senior Director of Quality Assurance and Regulatory Affairs and oversees budgeting, staffing, and cross-functional collaborations for new product launches.

The position emphasizes leadership, strategic planning, and enforcing quality systems across ISO and QSR standards, to support company-wide compliance and continuous

Qualifications

• Bachelor’s degree in Engineering, Sciences or Business; MS preferred.
• Ten years of Quality experience with at least five years in a management capacity.
• 3–5 years of experience working with sterile medical devices.
• Knowledge of ISO and QSR requirements in the medical device industry.
• Experience with FDA regulations and ISO standards (21 CFR Part 820, 11, 806; ISO 13485; EU MDR).
• Strong leadership, planning and communication skills.

Responsibilities

• Mentor, train and provide technical support to the Quality Assurance Engineering Group.
• Provide feedback and performance reviews.
• Administer and enforce company policies; manage performance and career development.
• Provide guidance and leadership to the QA Engineering group; manage resources.
• Coordinate and support internal audit program and compliance activities.
• Participate in internal quality auditing system and external regulatory audits/inspections.
• Develop and implement quality system procedures (ISO and QSR).
• Assist design projects for new product introduction ensuring compliance.
• Maintain quality system; generate trend reports for audits.
• Implement process improvements across the organization.

Skills

Leadership

Quality assurance

Regulatory compliance

Cross-functional collaboration

Training and development

Education

MS preferred

Bachelor’s degree in Engineering, Sciences or Business

Tools

Microsoft Office 365

Job description

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Category: Regulatory Affairs Quality Assurance

Location: Union City, CA, US, 94587

About Company

Mizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outcomes in spine and orthopedic surgeries along with disposable and reusable surgical patient care products.

Job Summary

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.

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.

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.
• 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.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Salary range: $172,000- $198,000 DOE + annual potential bonus + comprehensive benefits package

EOE STATEMENT

Mizuho OSI is an Equal Opportunity Employer and makes business decisions based on job related criteria only. Company policy prohibits unlawful discrimination based on race, color, religious creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, sexual identity, or any other consideration made unlawful by federal, state or local laws.

Mizuho OSI conducts criminal conviction background checks and drug screening through a third-party screening vendor which includes searches of address history, criminalconvictions,court records,education verification, employment verification, and reference checks. In addition, depending on the nature of the position for which you are applying, a motor vehicle driving report, a credit report, and/or ID checks in other non-U.S. countries are also included.

Criminal conviction background checks will run after an applicant has received and accepted a conditional offer of employment. After a conditional offer is made and before any background check is performed, applicants will receive background check disclosure and consent forms under state and federal laws, such as the Fair Credit Reporting Act and the Investigative Consumer Reporting Agencies Act. Existence of a criminal record is not an automatic bar to employment. An assessment will be made about whether the conviction has a direct and adverse relationship to the job in question. No job offer will be withdrawn, and no adverse action will be taken against any employee, based on the results of a criminal conviction background check, without an individualized assessment of whether the applicant’s conviction history has direct and adverse relationship with the specific duties of the job in question.

Top Reasons To Join The Mizuho OSI Team

Privately held company with a tradition of market leadership and best-in-class innovation

Fast-paced entrepreneurial culture focused on dramatically improving patient outcomes through personal empowerment

Emphasis on continuous improvement and celebration of our values of R.E.S.P.E.C.T. and the Mizuho OSI Way

Create innovative solutions designed and manufactured at our HQ in Northern California

The Mizuho OSI Way

In 1978, we set out to change the way patients undergo surgery. As a Mizuho OSI customer, you can expect our commitment to the following...

• We commit to your satisfaction. If you are dissatisfied, we will strive to make it right.
• We do things the right way. We commit to hire people with competence, generosity and a caring attitude.
• We motivate our employees to use their individual strengths to provide creative solutions, changes, and innovations.
• We anticipate your needs through customer experiences, thus nurturing our relationships.

Collectively, this creates an environment that enables and inspires healthcare professionals to improve the lives of patients.

Dare to go further. Care to do more.

BENEFITS

At Mizuho OSI, we believe better solutions and decisions are born of diversity and are proudly an EEO/AA employer. We offer a comprehensive benefits package that includes: medical, dental, vision, life insurance, 401k with matching, educational assistance and more.

FOR OUR SERVICE MEMBERS AND VETERANS

Mizuho OSI values the service Veterans and their family members have given to our country and we support the hiring of returning Service Members and military spouses. If you are a Veteran or wounded warrior and would like assistance with the employment process at Mizuho OSI, please contact HR at [phone].

FOR PERSONS WITH DISABILITIES

If you are a person with a disability or a disabled Veteran and are applying for a job with Mizuho OSI, we would like to ensure your application process goes as smoothly as possible. If you need additional assistance, information or answers to your questions, feel free to contact HR at [phone].