Job Description

Key Responsibilities:

• Manager Supplier communications related to product quality of received parts/material, and other sustaining Supplier Quality matters such as NOCs.
• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for receiving components/ materials based on engineering principles; analyze results, make recommendations, and develop reports.
• \xe2\x80\x8bManage supplier corrective actions from initiation to closure
• Plan, direct, and approve supplier validations, capability analyses and gage studies based on risks identified in FMEAs
• Oversee and develop supplier metrics such as PARETO charts and/or control charts.
• Continually assess the Supplier Management and QA Management system and SOP\xe2\x80\x99s for continual improvement
• Drive Deliverables to obtain Supplier Approval.
• Conduct onsite supplier audits
• Manager Supplier issues close collaboration with the Supply Chain stakeholders.

Education and Experience:

• Bachelor\xe2\x80\x99s degree in engineering or scientific field and 4 years related experience, or Master\xe2\x80\x99s degree in engineering or scientific field and 3 years related experience
• Previous medical device or pharmaceutical industry Supplier Quality experience
• Ability to travel up to 25%

Preferred Qualifications

• ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor or Six Sigma Black Belt certified preferred
• Audit training, ability to develop an audit plan, execute, and write effective audit findings.
• Experience in Product/Process investigations, validations, and statistical analysis

Additional Skills:

• Ability to conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR\xe2\x80\x99s and SCAR\xe2\x80\x99s
• Strong geometric dimensioning and tolerancing (GD&T) knowledge for print specifications
• Thorough understanding of Root Cause Analysis principles, FMEA process and development, GR&R and process capability
• Thorough understanding of Process Validation (IQ, OQ, PQ)
• Ability to develop statistically appropriate inspection plans at suppliers that incorporate critical to quality features and risk analysis
• Strong understanding of manufacturing processes like injection molding, extrusion, machining, etc.
• Thorough understanding of risk management principles
• Strong communication and organizational skills to effectively manage and get results with external suppliers
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Strong problem-solving, organizational, analytical and critical thinking skills
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $101,000 to $142,000(highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

Edwards Lifesciences