Targeted Salary Range: $110,000 - $140,000
Benefits include: Medical, Dental, and Vision Insurance, 401(k), Stock Options

NOTE: You must have 3+ years experience in quality, regulatory, or operations to be considered for this role. Local candidates only.

Providence Medical Technology, Inc. is a privately-held medical device company focused on innovation solutions for cervical spine conditions. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market.

Our purpose is to improve clinical outcomes for high-risk patients and prevent surgical failures of the cervical spine.

LOCATION

We are currently hiring on-site in Pleasanton, CA.

MAIN RESPONSIBILITIES:

• Sustaining engineering support for our Contract Manufacturer (which is located in Costa Rica).  Support the efficient production of products addressing quality and/or process issues as they arise.
• Work in a high growth environment assisting in the enablement of contract manufacturers and suppliers to meet exponential growth curve of the company.
• Support process validation activities as needed.
• Perform the following activities as needed:  Document & drawing updates, Environmental monitoring, Supplier quality activities, CAPA, complaint & NCR investigations, and other similar activities.
• Lead/support the continuous improvement of Manufacturing & Quality System procedures, forms, records to ensure consistent execution and continued compliance with all appropriate regulations and standards. Lead related training as appropriate.

• Support maintenance of the Risk Management process, ensuring that risk management activities are executed timely throughout the development process and product lifecycle (e.g. early hazards analysis, FMEAs). The risk management activities will be executed collaboratively with all relevant departments. 
• Understand the Providence Design Control process and work with the Project Lead to ensure compliance throughout the project execution.

• Perform supplier assessment/audits as needed.
• Support the development of manufacturing and supplier metrics to facilitate effective management of the production process.  Analyze metrics to help drive stable production and continuous improvement.
• Assist in the preparation of Management Review content for senior leadership.
• Support FDA, Notified Body and other QS audits as necessary.
• Support post-market review activities as appropriate.
• Ensure ongoing compliance to applicable regulations, standards and guidance documents.
• Support the analysis of needed QMS updates as changes occur.
• Help champion a company-wide culture of Quality and Compliance.
• Answering questions / support / reference for team.
• Position will require occasional supplier/contract manufacturer visits including 2+ visits to Costa Rica each year.

QUALIFICATIONS:

• BS or MS in life science, chemical, mechanical, quality engineering or related field
• 3+ years of industry experience in Quality, Regulatory and/or Operations
• Strong working knowledge of GMPs and ISO 13485/MDD/MDR regulations dealing with Class IIb and III medical devices
• Recognized Auditing Certification preferred

REQUIRED SKILLS AND ABILITIES:

• An action-oriented attitude and willingness to help out the team in any way.
• Technical experience with medical device development and manufacturing.
• Excellent attention to detail & strong critical thinking skills.
• Experience with CAD programs.
• Strong organizational and time management skills.
• The ability to manage multiple tasks simultaneously.
• Exceptional communication skills, including writing skills.
• An analytical thinking process and above-average computer literacy.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel, suppliers, consultants, contractors, etc.