Daniel Rakers Email & Phone Number

San Jose, California, Us

Marlborough, Ma, Us

Sr. Quality Compliance / Systems AnalystIn charge of gathering and presenting Bay Area site metrics for (3) Boston Scientific Sites. Monthly Business Review, Quarterly Management Review, Quarterly Signals Review & CAPA Board Review, and coordinate responses CAPA Board Review and responses to Metrics identified as RED based on Business Goals. CAPA Mentor/CAPA Coordinator across multiple sites. – CAPA/NCEP Owner. Compile requested data for Worldwide Compliance and Regulatory Submissions, License Renewals, and Site Master File updates. Gather data and responses to Worldwide Agencies with regards to Product Complaints, Injuries, and other concerns. • Led the creation of an improvement project leading to $387k annual cost avoidance by consolidating multi-site metrics and data distribution.• Enabled $219k annual cost avoidance and increased efficiency by leading the team creating tracking software, new work instructions, and templates. Project clarified task monitoring that ensured audit compliance.• Supported Legal requests with Analysis or SME requirements for Product Complaint cases.• Assisted in engineering activities to ensure risk levels are identified and met business requirements.• Reviewed and Monitored Quality Project Tracking Plans to ensure content sufficiently addresses Key Project Deliverables, mentored project owners on Quality Project tracking Plans requirements, and required objective evidence for Key Project Tasks identified.• Served as the Site Lead for Manufacturing/Distribution Licensing and Certificate Monitoring and update requirements.• Offered assistance to multiple departments with Quality Compliance questions pertaining to Design / Development.• Reviewed Protocols for Verification Validation requirements and final review of results to ensure testing results satisfy the identified criteria.• Tracked & ensured site training requirements are met to ensure ongoing compliance with regulations.

Marlborough, Ma, Us

ISO 13485:2003/9001, cGMP and FDA standards.Supported of our production department to ensure all Quality related aspects of our production builds are being met. Assisted with vendor audit requirements. Aided R&D department with new product development as well as software support for system control software and related tooling requirements. Functioned as the Quality Representative for Engineering Design Control Activities. Helped the Manufacturing engineering department with production issues or needs. Offered documentation support for all products as well as procedure writing, work instructions, method sheets, etc. U.L. and M.E.T. & TUV Lab support agency audits related to our laser systems and related documentation.• Supervise personnel to ensure compliance and efficient processing of raw materials and non-conforming materials. Training of personnel on newly released procedures and reports to ensure quality data gathering to assist with quality metrics.• Reviewed failure analysis and Customer complaint handling of all Laser systems & Fiber Optic Devices and related materials and accessories.• Interfaced with customers to address customer concerns with regards to return product complaints.• Processed C.A.R’s - P.A.R’s - S.C.A.R’s (Corrective action Requests) (Preventive Action Requests) (Supplier Corrective Action Requests) CO’s (Change Orders) to assist in generating a quality product that will meet or exceed our customers’ expectations. Support customer’s position requirements of Non-Conforming Products.• Served as Field Support for products and personnel to ensure our customers’ needs and requirements are being met to the highest of standards. Assisting Quality personnel with any related needs on day-to-day activities.• Led department organization and upkeep for the Quality areas to ensure process/evaluation flow is not hindered by daily activities.

Worked on cross functional teams designing new Laser Systems for use in Medical applications.Training of field engineers and distributors on technical service needs/requirements world wide.Support manufacturing with moving products from initial release to production to full release.Working with Marketing/Sales during clinical trials, support field service requirements during initial release until personnel are sufficiently trained.

Engineering

Education record