Manager, Supplier Quality Engineer - Pleasanton, CA

Calyxo • Pleasanton, CA

9d • $155,000 - $195,000

About The Position

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Summary: Overall responsible for developing, implementing, maintaining, and overseeing all aspects of Calyxo’s Supplier Quality Engineering program and ensuring the necessary systems, procedures, and processes are established to support both current and future business needs. Oversee all aspects of supplier management including supplier evaluations, supplier selection/approvals, supplier maintenance, supplier performance monitoring, and supplier improvement/development activities. In this position, this person will work in conjunction with the Operations and R&D functions in selecting, managing and maintaining the supply base, driving acceptable supplier performance, pursuing supplier improvement activities/initiatives, and implementing and overseeing strategic supplier management programs such as Supplier Certification, Alternative Inspection Methods, Supplier Performance and Recognition, and Continuous Improvement initiatives. The Supplier Quality Engineer Manager will ensure the implementation of company-wide quality systems policies and procedure as they relate to Supplier Management and Supplier Quality and will manage associated staff to support Calyxo’s Supplier Management Program.

Requirements

• Bachelor of Science in Engineering or Life Science discipline.
• 12+ years overall experience in Quality Engineering/Assurance with a minimum of 5 years in Supplier Quality Engineering; minimum 5 years experience in medical device manufacturing or pharmaceutical industries.
• Minimum of 5 years of experience managing and developing teams, with proven ability to lead people, set priorities, and drive departmental goals in a regulated quality environment.
• Demonstrated knowledge of applicable regulations and standards such as FDA, QSMR, ISO, MDR, & IVDD.
• Strong written, oral, and interpersonal skills.
• Trained and experienced Lead Auditors in conducting external Quality System assessments (preferably a Certified Lead Auditor).
• Strong analytical skills, problem solving techniques and statistical application experience.
• Knowledge in the areas of Supplier Management, Design Controls, Process Validation, manufacturing practices, and statistical techniques.

Nice To Haves

• Experience with Class II and III sterile devices preferred.

Responsibilities

• Implement and maintain the effectiveness of the Quality System as it relates to Supplier Quality Management.
• Develop, prioritize, provide direction and monitor progress toward Supplier Quality Engineering department goals, objectives, and initiatives.
• Manage Supplier Quality Engineering staff to ensure ample coverage and support for Operations and R&D projects and product approval and release activities as it relates to external suppliers.
• Ensure the Calyxo Approved Supplier List and corresponding supplier files are maintained and accurate.
• Drive and support continuous improvement plans and activities at suppliers
• Ensure appropriate validation and qualification of applicable supplier processes, methods and equipment at suppliers.
• Ensure the on-time completion of all required supplier maintenance activities such as quality audits/assessments, process audits, business reviews/assessments, regulatory assessments, quality contract/agreements and performance monitoring/feedback with suppliers.
• Serve as Subject Matter Expert (SME) during internal and external audits as it relates to Calyxo’s Supplier Quality Management program.
• Ensure the hiring and development of qualified Supplier Quality Engineering staff, provide growth path/opportunities and professional development and guidance as appropriate.
• Establish and maintain successful cross-functional relations with internal departments/functions such as Operations/Manufacturing, R&D/Engineering, Quality Control and Regulatory Affairs.
• Manage department expenses in line with approved department budgets.
• Fulfill day-to-day Supplier Quality Engineer activities as described in the Supplier Quality Engineer job description, as necessary.
• Support department specific initiatives and projects as assigned.
• Domestic and International travel to suppliers and contract manufacturers as needed (15-30%)

Benefits

• A competitive base salary of $155,000 - $195,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees