Energetic and passionate Technical Service / Quality Engineer with an entrepreneurial spirit and strong technical writing and communication skills who will support Quality activities of the Technical Services Engineering team. Support process in compliance with ISO 13485 and FDA 21 CFR 820 Quality Systems Regulation. Work with Technical Services and Quality Assurance teams to implement and support processes.
· Work with SMEs to author and edit Quality Management System (QMS) processes as required
· Participate in Feedback process (field service reports, clinical case reports, customer satisfaction surveys, etc.) and ensure proper documentation.
· Support the documentation and review of service work orders (Service Records, Customer feedback tickets, etc.) and activities for QA compliance and disposition.
· Ensure proper handling & closure of support and commercialization related CAPAs incl. task tracking, root-cause analysis, and completion of documentation.
· Support and provide input to continuous improvement process resulting from lessons learned.
· Travel to and participate in service calls, installations, and cadaver labs as necessary to maintain practical field service process knowledge.
· Ensure Service tooling is calibrated and maintained in accordance with SOPs.
· Support achievement of quality objectives and requirements by working with the cross-functional team
· Assist with the implementation, validation, and maintenance of software systems, including but not limited to: Service Management Software (SMS), Customer Relationship Management (CRM), Complaint, Training, etc.
· Support documentation of logbooks as needed for Quality Records, such as Feedback, Complaints, CAPAs, Training, etc.
· Support external audits through back-room documentation retrieval and SME prep, or front room scribe duties.
· Facilitate and support quality and engineering in the investigation and resolution of complaints.
· Support maintenance of training records for Employees and Customers
· Support overall cross-functional compliance to Good Documentation Practices (GDP) & Good Manufacturing Practices (GMP).
• Bachelor’s degree or equivalent in an engineering field, or current enrollment in a Bachelor’s of Engineering program.
• Experience in the medical device industry an asset.
• Familiarity with ISO 13485 and FDA 21 CFR 820
• Strong technical writing and communication skills
• Strong organizational and project management skills
• An appreciation for the documentation supporting successful process execution
Indications for use: The Anovo™ Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Anovo™ Arms during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Anovo™ Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo™ Surgical System are indicated for the following benign procedures: Total Benign Hysterectomy with Salpingo-Oophorectomy • Total Benign Hysterectomy with Salpingectomy • Total Benign Hysterectomy • Salpingectomy • Oophorectomy • Adnexectomy • Ovarian cyst removal. Caution: The safety and effectiveness of the Anovo™ Surgical System was established only for the representative uses mentioned in the Indications for Use. The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying is ease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon. The prescription-use symbol or “Caution: Federal law restricts this device to sale by or on the order of a physician.” For safety information, including risks, indications, and specific warnings and cautions related to the Anovo™ System please refer to the Anovo™ Surgical System Instructions for Use provided with your Anovo™ Surgical System.