Quality Engineer II- Post Market Surveillance - Nihon Kohden Orange Med

Job Purpose
This position is responsible for providing support for the RA/QA department to ensure efficient and compliant QMS processes and environment. The position is responsible for identifying data needed, obtaining the data and ensuring that data is effectively presented for trending and analysis as part of post-market requirements. This individual will collaborate with various departments to gather data from multiple sources including complaints, field safety actions, risk management, non-conformances and manufacturing data for reporting.

Duties and Responsibilities
Assumes responsibility for collection and trending of Post Market Data

• Collaborating across departments to obtain information necessary for post market surveillance activities, maintain accurate records and operational metrics, and ensure compliance with regulatory requirements.
• Collect, analyze, and interpret post market data to identify trends, anomalies, and potential product issues to support proactive product quality improvement initiatives.
• Collaborate cross-functionally with quality, regulatory, clinical, manufacturing and R&D teams to fulfill ad-hoc data requests and deliver detailed analysis of PMS data.

Assumes responsibility for facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports

• Leads document creation for post market surveillance activities including PMS plans and periodic safety update reports (PSUR).
• Responsible for compiling data and preparing reports at periodic intervals as required by regulations.

Assumes responsibility for coordination of audit activities

• Monitor to ensure audits are performed as scheduled.
• Participate in internal/external audits as necessary representing the post market activities.
• Work to collect and analyze data, drive rigorous root cause analyses and facilitate cross-functional discussions to ensure complete resolution of issues identified during audits.
• Maintain log of audit findings and ensure timely closure.

Assumes responsibility for preparation of Management Review information.

• Collection, creation and compilation of information into PowerPoint presentation format.

Assumes responsibility for continuous improvement of Quality Management System.

• Develop or maintain Quality System Processes in compliance with US-FDA, EU MDR, ISO 13485 and other applicable country specific medical device regulations.
• Support validation of new or updated computer systems used in QMS and facilitate their implementation including generation or protocols, reports, quality plans, as required.

• Adheres to all company policies, procedures and business ethics codes.
• Perform other related duties and assignments as needed.

Qualifications
• Bachelor’s degree in a technical field such as engineering or biological science with a minimum of three years’ experience in a quality role, prior experience with medical electrical equipment preferred.
• Strong analytical problem-solving ability required with good understanding of statistical and data analysis techniques and tools.
• Proficient computer skills which include the use of Microsoft WORD, EXCEL, and POWERPOINT. Prior use of statistical software, electronic document control system, ERP system and FDA eMDR reporting is a plus (e.g. Minitab, SAP, MasterControl, AssurX).
• Understanding of US FDA and EU Medical Device regulatory requirements including post market surveillance. Woking knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820.
• Effective technical writing and verbal communication skills.
• Great attention to detail with excellent organizational and coordination abilities.
• Ability to work independently, being highly motivated with strong time management skills.
• Ability to perform in a time sensitive and deadline driven environment.
• Ability to make and present risk-based decisions
• Fluent in English (fluency in other languages are a plus).
Desirable Accreditation/Knowledge
• Statistical Methodology and Analysis
• Certified Six Sigma Belt
• ASQ Statistics Training & Statistical Analysis Courses

Working Conditions
• Usually works in an office environment which includes laboratory and manufacturing areas. Occasional domestic or international travel may be required on an as needed basis.
• Works a standard work week onsite and may be required to work some evenings and weekends to meet the needs of the company.

Physical Requirements
• Must be able to type using the keyboard of a computer.
• Must be able to talk, listen and speak clearly on the telephone.
• Must be able to lift and carry up to 50 lbs.