Amaranth Medical is hiring!
Amaranth Medical Inc is dedicated to advancing the practice of medicine and improving the long-term health of patients worldwide. We strive to become the new global standard of care for stent interventions. Our success depends on talented and motivated individuals who share our passion for making a difference in patients’ lives.
We are a young and vibrant company located both in Mountain View, California, and in Singapore. We pride ourselves on a highly collaborative, multidisciplinary environment where initiative and teamwork are valued and individual efforts are recognized. We offer a competitive, comprehensive benefits package.
Competitive Compensation Package
- Competitive salary
- Pre-IPO stock options
- Medical, dental, and vision insurance
- 401(k) plan
- Paid time off (PTO)
Position Title: Sr. Quality Engineer
Reports To: VP, Quality Affairs FLSA Status: Exempt
Summary of Responsibilities: Ensures that all Quality System activities are conducted and documented in accordance with appropriate industry, regulatory standards and Company procedures.
- Provide quality input/oversight supporting new product development and daily operations for the scaffold and delivery system manufacturing operations.
- Support all phases of the product design and manufacturing process development; incoming inspection, in process and finished product test.
- Assist in development of test specifications, protocols, sampling criteria and documentation activities to support all design and manufacturing functions.
- Ensures tests are compliant to established Standard Operating Procedures (SOP), Good Manufacturing Practices (GMP) as well as any applicable federal or international regulations and/or standards.
- Perform equipment, operational and performance qualification studies to verify each complies with design, operational and business expectations.
- Communicate effectively with Project Team members and Amaranth management.
- Ensure proper documentation of design/manufacturing changes (e.g. change control, data traceability) and integrity of data, calculations and results reporting in accordance with the internal Quality documentation system.
- Support the maintenance program for key test equipment and the ability to perform Gauge R&R studies on key instruments.
- 5+ years of industry experience in drug/medical device development or product development or combination devices.
- Understand FDA and notified body regulatory audit requirements.
- Observe and comply with site level quality policies, procedures and work instructions.
- Mentor and lead other team members in performing good quality manufacturing practices.
- Be a positive, self-confident, decisive with excellent communication skills in both oral and written formats, as well as excellent listening skills
- Be known as a person who has high integrity, sound character, a tremendous work ethic, excellent team player, and the passion to succeed.
- MS or BS Engineering and/or Science related field
- Relevant Quality Assurance experience desirable
The above statements are not intended to be construed as an exhaustive list of all responsibilities.
If you’re looking for a career that enables you to pursue both professional and personal goals, we invite you to consider a career at Amaranth Medical, Inc. Please forward your resumé to email@example.com for consideration.
Amaranth Medical Inc. is an equal opportunity employer.