Quality Engineer

Responsibilities

• 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.
• 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.
• Track, trend, and monitor 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.
• Perform other related duties and responsibilities, as assigned.

Qualifications

• Engineer Bachelor’s degree in Engineering or technical field, equivalent experience required.
• 1 - 2 years of experience working in quality and/or quality engineering roles, preferred in the medical device manufacturing industry.
• Engineer II Bachelor’s degree in Engineering or technical field, equivalent experience required.
• 2 - 5 years of experience working in quality and/or quality engineering roles, preferred in the medical device manufacturing industry.
• Working technical knowledge and application of quality concepts, practices, and procedures.
• 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.
• Able to work, interact, and communicate effectively with others.
• Able 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.
• Auditor or Lead Auditor certification, preferred.
• Experience with EU MDR 2017/745, preferred.
• Experience with ISO 14971, preferred.