Quality Engineer II

stratasys•Hopkins, MN

About The Position

Stratasys is a world leader in 3D printing! Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care. The Quality Engineer II will provide ongoing quality support to manufacturing with a focus on preventing product manufacturing variability from affecting product performance with customers. This position manages customer and field complaints, manufacturing and supplier quality, and supports validation activities and new product introduction (NPI).

Requirements

Bachelor’s degree in Engineering (focus on Chemical, Materials Science, Polymers, Composites preferred)
4+ years engineer experience in a manufacturing environment
Experience working in regulated environment and knowledge of ISO9001
Knowledge of quality control methodologies, control plans, and statistical analysis
Able to lead Root Cause Analysis (RCA), such as CAPA or 8D
Experience with Non-conforming material investigation and disposition, including Deviation decision, description, documentation, and approvals
Strong verbal and written communication skills

Nice To Haves

Supplier or external engagement experience
Internal or external auditing exposure
Experience using tools such as Statistical Process Control (SPC)
Ability to teach/coach others,
Validation of processes and equipment (IQ,OQ,PQ), risk analysis, FMEA
Demonstrated ability to support project-related initiatives.
Basic knowledge in continuous improvement methodologies (Six Sigma Green Belt a plus)
ASQ CQA, CQE, SSBB certifications a plus

Responsibilities

Assure compliance with internal Quality Management System and standards and to external standards
Communicate and contain significant issues quickly and efficiently, identify and execute correction, share opportunities with others for consideration
Collaborate with engineering, suppliers, customer success, regulatory, and manufacturing teams to investigate and resolve quality and compliance issues
Lead CAPA efforts, assess and mitigate risk, support change requests and deviations
Perform analysis and identify trends at various points in the process, from raw to finished goods to customer complaints or returns and determine containment/correction when necessary
Support both existing and new process development/improvement activities
Train and mentor team members or other areas of the organization when necessary
Implement protocols, reaction plans, and methods to inspect and test in-process raw materials and finished products to ensure compliance with internal and external safety, quality and regulatory standards requirements for distribution
Perform initial supplier evaluations, material qualifications, or First Article Inspection
Assist with supplier audits and reviews (working toward leading audits) and ongoing performance monitoring
Coordinate the investigation and resolution of issues related to suppliers
Support continuous improvement projects, provide suggestions, and help develop tactical approaches to implement team strategies
Support on validation and qualification activities
Review/update SOPs
Follow all company safety policies and procedures
Attend all required company training
Demonstrate commitments to Stratasys Behaviors by leading, acting, and modeling these values
Other responsibilities as assigned by the department or manager