QA Manager

**QA Manager** **-** **(**30007083**)**

**Description**

**Why Ansell?**

Discover more about our company, our team, and our values by visiting us at Ansell.

**Ansell is looking for a QA Manager to join our team in Chatsworth, CA**

**_ The salary range for this position is $80,000 to $110,000 U.S. Dollars per year_**
- In this position you will play a vital role in managing overall compliance in testing standards, FDA QSRs, ISO 9001 and 13485 standards in a regulated environment. This position will oversee all processes and product specifications for the complete surgical product line. Responsibility for US Americas based Supplier Quality Program, corrective preventive actions, returned materials, complaint investigations, product verification, sampling and release. The position will serve as the technical expert and liaison for the Quality, Regulatory, Operations and Manufacturing teams.

**What benefits and opportunities does Ansell offer?**
- Competitive compensation plan, including a performance based annual incentive
- Flexible and hybrid work model
- An inclusive and collaborative environment that values diversity and fosters an international culture
- Ansell University programs to develop professional and interpersonal skills
- Opportunities to advance and grow within the company
- Health Benefits: medical, dental, vision, short term and long
- term disability and wellness programs
- 401-k plan with company match
- Paid time off (vacation, sick and personal days) plus 14 paid holidays
- Continuing Education Reimbursement
- Summer Fridays
- Regional Diversity, Equity & Inclusion committees
- Green office concept and a global mission of sustainability

**What your role will be?**
- Own the Quality Management System and Audit process
- Develop and maintain processes for technical projects, CAPA, product investigations, spec development and change management
- Determine process improvements for Quality Key Performance Indicators (KPIs)
- Ownership of field inspection resources, factory auditing, product inspection and investigations
- Provide technical guidance on product design
- Perform statistical analysis for in-process and final release quality control and processes
- Cultivate strong relationships with global suppliers, including Supplier Qualification, Corporate Social Responsibility (CSR), Supplier Development, Performance Measurement and Risk Management
- Implement and develop test methods when the industry lacks technical guidance
- Own technical files, risk management, product registrations, product specifications, bill of materials, design files and related documentation.

**What will you bring to Ansell?**
- Bachelor of Science degree in a technical field or commensurate experience
- 5 years’ experience in a Class I Medical Device company
- 1-2 years of experience managing FDA inspections in a regulated environment
- Experience with Six Sigma (Green Belt, Black Belt preferred)
- Sterilization experience preferred

***

**Equal Opportunity Employer**:
**Our Commitment to Diversity Equity and Inclusion**:
Ansell’s vision is about creating safe spaces where diverse perspectives are valued alongside individual contributions. It is our view that togetherness prevails over individuality.
- When we say that everyone deserves to belong, feel included and empowered at work, it's not just words. We want applicants to know that we are sensitive and thoughtful and provide an inclusive environment that will consider all, regardless of age, gender, background, disability, veteran status, or experience alone It’s what drives Ansell as an organization towards a workforce that reflects the diversity of our community, it’s what drives us to serve our customers and stakeholders with pride, and it’s also what differentiates Ansell. We believe everyone, no matter how that person self-identifies, deserves an opportunity to achieve success.

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**Primary Location**: United States-California-Chatsworth

**Job**: Quality

**Organization**: Global Product & Marketing

**Schedule**: Full-time

**Job Type**: Standard

**Job Level**: Manager

**Job Posting**: Apr 18, 2024, 2:58:27 PM