Operations Manager in Sunnyvale

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Job Description

Position Title: Operations Manager

Main functions: Responsible for managing suppliers and planning and executing the production and sterilization of SIESTA MEDICAL products as well as maintaining operations compliance to company Quality System and providing functional input and expertise to product development.

Duties:

• Manages suppliers of components as well as other outsourced manufacturing operations required for SIESTA MEDICAL Products.

Monitor FG inventory, component supply levels and sales forecast and order materials as needed.

Coordinate movement of materials from suppliers to contract manufacturers, sterilizers and test labs.

Act as point of contact and initiate builds with contract manufacturers.

Perform IQC and release of product or assign to others as needed.

Monitor and report Cost of Good and look for opportunities for improvement.

Research, qualify and requalify Siesta suppliers as needed.

Ability to creatively resolve supply chain issues to ensure on-time delivery of product.

• Provides ongoing functional leadership and support to product development projects via design input, process development and Design Review responsibilities.

Provide input for manufacturing and quality aspects of Siesta product (assembly methods, inspection methods, tools, inspection points, inspection criteria, etc.).

Develop procedures, specifications and qualifications/validations for assembly, packaging, process risk management and sterilization of Siesta products.

• Ensure Operations compliance to Siesta Medical’s Quality System.

Initiate corrective action and monitor progress for identified nonconformances.

Assist in customer complaints investigations and corrective actions as needed.

Monitor and coordinate with outside suppliers for calibration and maintenance of Siesta equipment.

Coordinate and document periodic requalification of Siesta sterilization processes.

• Manages the activities of others as needed.

Education/Experience/Certification Requirements:

• Broad Operations background in the medical device industry with demonstrated leadership responsibility.
• Minimum of 7 years of experience in the Medical Device industry with previous experience in management of the Operations function (preferable).
• Hands-on experience with a variety of inspection and manufacturing tools.
• Experience with EO and radiation sterilization processes (preferable).
• Knowledge of applicable Quality System requirements (e.g. FDA 21CFR, ISO and MDD requirements) is required.
• Ability to clearly articulate thoughts and communicate verbally as well as in writing.
• Ability to lift and move up to 50lb.
• Bachelor of Science in Engineering field or similar

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