Job Summary

The Quality Engineer assumes primary responsibility for managing the quality systems and processes for the division including the preparation, application registration, and continued compliance related to ISO certifications.  This role, in collaboration with the operational leadership, is responsible for setting up the systems and processes to ensure product specifications and standards are understood, communicated, monitored, and produced. The quality engineer collaborates with and supports both Program Management and Operational team members throughout the product lifecycle. In addition, ownership and involvement with the ISO 9001 Quality Management System / IQMS Quality module and internal audit process are required.

Essential Job Duties/Responsibilities

• Complete comprehensive documentation packages such as PPAP and test data submissions.
• Accurately review and approve quality criteria and finishing requirements of customer materials and material processes.
• Collaborate with teams on quality, risk management, safety, and reliability.
• Collects and reports out on the required data and charts quality goals established by the management team.
• Supports measuring and analyzing key metrics to monitor and improve performance, which includes leading productivity improvements.
• Perform contract and feasibility reviews through the First Article, Sample, and Quotation Systems.
• Develop and forward formal customer corrective action reports.
• Participate in customer conference calls and visits when required.
• Respond to requests for assistance from Production, Pricing, and Customer Service.
• Develop, select and enter process programs and correlate work instructions into the computer system.
• Assist in answering sales and customer questions or concerns pertaining to process and finishing requirements.
• Assist in troubleshooting process problems as they relate to product quality.
• Coordinate and participate in processing, testing, and disposition of rework material.
• Review documentation and certify the outgoing products.
• Collaborate with project teams to devise and implement methods and procedures for inspecting, testing, and validating system requirements.
• Coordinate with engineering team(s) to document, and implement part/material qualification plans, including the identification and use of inspection tools.
• Collaborate with project team(s) to assess the impact and determine root cause and corrective actions for products or materials that do not meet required standards and specifications.
• As needed, conduct the First Article, in-process, and final inspection.
• Support and champion quality system processes that support products in development and production environments.
• Participate in engineering and risk reviews and make recommendations to enhance the quality and manufacturability of new designs.
• Engages in product development activities to ensure continued compliance with internal procedures and applicable regulatory and international standards.
• Performs other miscellaneous job duties and related functions as needed.
• Develop a pathway to Zero defects.

Experience and Qualifications

• A College Degree in Quality Engineering with a minimum of 5 years of Quality Engineering experience, preferably in the medical device or a related industry. An equivalent amount of directly related experience will be considered in lieu of the College Degree.
• Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485:2016.
• ISO knowledge and training (ISO 9001:2008/2015 and ISO 13485:2016).
• Experience leading organizations through the quality journey to develop a culture of quality and attain ISO certifications.
• Experience participating in internal and external audits (e.g., FDA, Notified Body, Supplier) preferred.
• Experience with CAPA, complaint investigation, field action processes and risk management.
• Certified Quality Engineer, Cost of Quality Audit preferred.
• Advanced Metrology skills - Geometric Dimensioning & Tolerancing.
• Strong General Manufacturing Practice and current Good Document Practices 1, 2 & 3 knowledge.
• Blueprint reading / GD&T.
• Well-versed in Quality tools such as Lean manufacturing, TPE, Mistake proofing, Kaizen and 5-S
• PFMEA (Process Failure Mode Effects Analysis) experience
• IQOQPQ (installation Qualification, Operational Qualification, Performance Qualification) knowledge and experience
• APQP (Advanced Product Quality Planning) experience.
• Good working knowledge of Supplier Quality Engineering competencies.
• Strong knowledge of statistical analysis.
• Individuals must have a hands-on approach.
• Strong organizational and time management skills.
• Ability to resolve issues quickly and recommend preventive solutions.
• Negotiation skills, including an understanding of escalation paths.
• Strong computer skills; skilled in Excel, Word, PowerPoint, Minitab, Smartsheet.
• Excellent communication and interpersonal skills.

Physical Requirements

• Must be able to work in a fast-paced environment and walk up and down stairs several times per day. 
• Must be able to occasionally lift parts up to 35 lbs.
• 50% of a day is spent stationary or on the computer.
• 50% of a day is spent walking or standing.