We are seeking a Quality Engineer with experience in medical device design quality and risk management to support product development from concept through commercialization. This role will primarily support R&D and Process Engineering activities to ensure compliance with design controls and risk management requirements.

The ideal candidate must have hands-on experience with design controls and risk management, including FMEA and structured problem-solving methodologies, and a solid understanding of ISO 13485, 21 CFR 820, and ISO 14971 requirements to identify and mitigate potential compliance, product and patient safety risks. 

Objective:

The objective of this position is to provide the level of resource necessary to maintain, monitor and improve the Quality Management System (QMS) for Ambu USNV, to ensure compliance with regulatory requirements and established local and Corporate practices.

Responsibilities and Essential Functions (Applicable to all positions listed above):

• Identify and implement effective quality control systems to support on-going manufacturing and product/process development activities to meet internal and customer requirements.
• Assist in the improvement and streamlining of quality practices across the organization to effectively identify and resolve quality issues.
• Apply sound and systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Responsible for product and process risk management activities.
• Support the review, investigation, resolution and prevention of product and process nonconformances (NCRs) to meet established internal requirements.
• Develop rework procedures to support NCR activities.
• Act as a handler for Corrective Actions/Preventive Actions (CAPA) system activities to drive proper risk evaluation, investigation, and implementation of actions.
• Support CAPA verification of effectiveness (VOE) activities.
• Tracking, trending, and monitoring Quality key performance indicators (KPIs).
• Report quality KPIs to Quality Review Board (QRB).
• Participate in CAPA Review Board (CRB) meetings, as necessary.
• Review calibrations out of tolerance assessments (OOTAs) and support with calibration remedial actions reports (RARs).
• Responsible for change control activities related to quality documentation, such as updates to procedures, instructions, forms, risk management documentation, etc.
• Quality functional approver for product and process changes as a subject matter expert (SME) of assigned areas.
• Support Document Controls activities, as necessary.
• Develop new and/or improve quality documentation (procedures, instructions, forms, ect.).
• Write and execute spreadsheet validation documentation, as necessary.
• Provide quality engineering support to process improvements and product/process development projects to ensure implementation of highest quality solutions.
• Support complaint investigations, as necessary.
• Become part of the internal auditing team as a certified auditor.
• Supporting backroom activities during external audits, as necessary.
• Provide guidance to less experienced staff.
• Perform other related duties and responsibilities, as assigned.

Responsibilities and Essential Functions - Engineer II, Quality:

• Responsible for, at a minimum, one critical functional area of the Quality Management System (QMS) (e.g., CAPA, NCR, Deviations, etc.).
• Identify and implement activities geared to standardize and streamline quality practices across the organization to improve QMS efficiency and maintain its effectiveness.
• Lead and provide guidance to the rest of the organization in proper root cause investigation techniques.
• Provide guidance on the use of statistical techniques for selection of sampling strategies and analysis of data.
• Facilitate CRB, QRB, and Management Review meetings.
• Responsible for data trending and preparation for Management Reviews and Corporate Management Reviews.
• Write and execute Test Method Validation (TMV) documentation related to Quality Assurance inspection methods, as necessary.

Qualifications:

Level: Engineer

• Bachelor’s degree in Engineering or technical field equivalent experience.
• 1 - 2 years of experience working in quality and/or quality engineering roles.  Within the medical device manufacturing industry is preferred.

Level: Engineer II

• Bachelor’s degree in Engineering or technical field equivalent experience.
• 2 - 5 years of experience working in quality and/or quality engineering roles.  Within the medical device manufacturing industry is preferred.
• Working technical knowledge and application of quality concepts, practices, and procedures.

Required skills:

• Experience with ISO 13485 and/or 21 CFR Part 820.
• Ability to travel nationally and internationally up to approximately 5% of a year’s time.
• Good attention to detail and organizational skills.
• Proficient at applying analytical and problem-solving tools and methodologies.
• Ability to work, interact, and communicate effectively with others.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Effective verbal and written communication skills.
• Great technical writing skills.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Must be able to read, write and understand English.

Preferred skills:

• Auditor or Lead Auditor certification.
• Experience with EU MDR 2017/745.
• Experience with ISO 14971.

Work Environment:

This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.