Director, Quality Engineering Production Support

15046BR

Job Description:

Develop and implement strategies to enhance product quality and compliance. Manage team members to lead multiple quality operations projects that support the manufacture of medical devices. Assist executives and/or senior directors in defining organizational goals and strategic plans. Collaborate closely with management and staff in Manufacturing, R&D, Regulatory, and other Quality areas to support manufacturing process changes, manufacturing transfers, product design improvements and transfers, implementation of new products, and the enhancement of quality management system compliance. As owner of product non-conformance procedure, responsible for timely execution and closure, implementation of actions, corrections, material disposition, monitoring performance of the NCR process, and providing KPI’s to the Quality Leadership team.

Working with senior quality management, develop and implement strategies to enhance product quality and compliance

1. Develop guidelines and complex processes/procedures for quality engineering groups to enhance performance

2. Manage managers, engineers, and technicians who support the manufacture of medical devices

3. Manage managers and quality engineers who work with Manufacturing Engineering and R&D to review process changes and resolve quality issues

4. Manage quality engineers who lead activities to investigate corrective actions associated with nonconforming product and customer complaints

5. Manage quality engineers who lead projects to improve the quality management system, including remediation projects and cost reduction opportunities

6. Execute product holds in the system to prevent inadvertent release of non-conforming goods

7. Coordinate and execute activities related to Engineering Order, Quality Plan, Quality Improvement Project to support business needs, corporate strategies, and Global Quality objectives

8. Effectively communicate and collaborate with other departments as needed to achieve Quality Engineering and company goals

9. Resolve critical issues and contribute to organizational development

10. Define functional goals and objectives for the team and monitor performance throughout the year

11. Make strategic decisions based on company goals and objectives

12. Support internal and external inspections as Subject Matter Expert in front room

13. Control functional budget and expenses and responsible for resource allocation

14. Escalate quality and compliance issues to senior quality management and propose and work on effective solutions

15. Contribute to the design and improvements of workflows in the ERP software for processes related to product hold, traceability, and materials management

16. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization

17. Perform additional duties as assigned

Qualifications:

1. Bachelor’s degree in a related field of study

2. A minimum of twelve (12) years of related professional experience in quality, R&D and/or manufacturing

3. A minimum of five (5) years of management or leadership experience

4. Extensive medical device industry experience and business knowledge with comprehensive understanding of the organization and functional area

5. Excellent command of FDA and ISO medical device quality system requirements

6. Excellent knowledge of medical product manufacturing, process validation, test method validation, and risk management

7. Excellent ability to provide technical leadership in evaluating product quality issues

8. Excellent verbal and written communication and interpersonal skills

9. Excellent in negotiating and influencing skills

10. Proficient with MS Office Suite, SAP, and statistical software (preferably Minitab)

11. Ability to be onsite 5 days a week

Desired Qualifications

1. Master’s degree in a related field of study

2. Ability to understand the technology related to MicroVention’s products

3. Experience with software used to manage quality information

4. Experience with the auditing process

Physical Qualifications

1. Extended periods of computer use

2. Extended periods of sitting, standing, or speaking

3. Light lifting, up to 25 lbs

4. May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs)

5. Travel approximately 5 to 15%

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

Posting Country:

US - United States

Title:

Director, Quality Engineering Production Support

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.