The Senior Quality Engineer – Materials will provide ongoing quality support to manufacturing with a focus to prevent product manufacturing variability from affecting product performance with customers. This position manages supplier quality including support on new product introduction (NPI).
• Communicate significant issues identified during quality activities and recommend process improvements. Prepares documentation for inspection/testing procedures.
• Collaborate with engineering and productions teams to investigate and resolve quality and compliance issues
• Lead or participate in corrective/preventative action teams in resolving production, customer, and supplier issues (nonconformances, containment, CAPA activities, and audit findings)
• Support supplier quality activities including evaluations and material qualifications. Assist with supplier audits and reviews. Provide technical assistance for First Article Inspection and ongoing performance monitoring. Support the investigation and resolution of issues related to suppliers
• Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products and ensure that they are in compliance with internal and external safety, quality and regulatory standards requirements for distribution
• Support continuous improvement projects by providing input for process improvement and help develop tactical approaches to implement team strategies
• Support on validation and qualification activities
As a part of Stratasys, this position requires access to information and/or technology controlled under the International Traffic in Arms Regulations (ITAR) or the Export Administration Regulations (EAR). The successful candidate must be a U.S. Citizen, lawful permanent resident of the U.S. (or, green card holder), protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.
• Bachelor’s degree in Chemical Engineering, similar field or equivalent experience
• Experience working in a regulated environment and knowledge of ISO9011 and AS9100
• Proficient knowledge of Root Cause Analysis (RCA) experience including leading CAPA
• Demonstrated experience as a Lead auditor
• Basic work in statistical analysis skills, including Statistical Process Control (SPC)
• Proficient experience in statistical/analytical skills for problem-solving with the ability to teach/coach others
• Demonstrated ability to lead projects and investigation teams
• Basic knowledge in continuous improvement methodologies and tools such as Six Sigma, Gauge R&Rs, etc.
• Fundamental experience with PFMEA’s and Risk Management
• ASQ CQA, CQE, SSBB certification preferred
To apply for this job email your details to firstname.lastname@example.org