Senior Quality Engineer

DUTIES/ RESPONSIBILITIES including but not limited to:  

• Responsible for In Process Quality Controls, day to day quality performance in manufacturing (e.g. DPMO, FPTY, MRB) and continuous improvement with systemic approaches 

• Readily available to solve real-time manufacturing quality issues while residing mainly on the production floor 

• Coordinates external audits, prepares the internal team, agenda and meetings  

• Supporting Site Quality Leader in registrar, customer and internal audits 

• Executes the internal quality audit programs for their respective site 

• Coordinate with Site Quality Leaders on decisions affecting QMS and maintenance of quality and environmental certifications and standards (ISO, IPC, etc.) for their site 

• Manages Suppliers Quality Performance, monitoring and determining systems to improve top hitters and assists with resolving supplier performance issues 

• Supports with training needs as required, providing guidance and coaching to QEs, and responsible for training and development of local quality engineering support personnel 

• Coordinates and conducts frequent cell level process layered audits with QE personnel and other site functional leaders 

• Assists with regional and site quality initiative projects 

• Assists to define achievable quality KPIs for their site 

• Supports and assists other Quality Engineers in the Customer Focused Team for systemic issues and CAPA resolution 

• Manages and collects systemic data for process improvement 

• Sustains knowledge of quality and regulatory changes applicable to their manufacturing site 

• Takes a systemic approach on initiatives that improve the quality system, using data and inputs from various processes and different accounts 

• Keeps Site Quality Leader fully apprised of significant occurrences and trends that impact the quality of processes, quality systems or supplier quality operations 

QUALIFICATIONS: 

• Minimum of 5 years’ experience in a manufacturing environment as a quality engineer or equivalent 

• Demonstrated working knowledge of ISO 9001 and 13485 standards is required 

• Work experience in a cGMP FDA 21 CFR Part 820, AS9100, AS9102 and ISO 14001 environment is strongly desirable 

• Working knowledge and comprehension of quality management systems, measuring techniques, tools and equipment 

• Strong technical skills required including electronics and electro-mechanical principles 

• Experience in a PCBA low volume high mix or PCBA NPI desired  

• Knowledge of Statistical Process Controls (SPC), implementation and reporting 

• Ability to lead problem solving activities with site level teams executing effective corrective actions 

• Familiarity with inspection practices and solder knowledge  

• Experience in the application of Lean and Six Sigma Methodologies – CSSGB or CSSBB desirable 

• A Degree in Engineering or related technical discipline, and/or a combination of education and experience is required 

• ASQ CMQ/OE, CQE or CQA certification highly desirable 

SKILLS REQUIRED:  

• Highly proficient in MS Office Word and PowerPoint with advanced knowledge in Excel 

• Excellent communication and interpersonal skills adaptable to all levels of the organization 

• Seasoned at providing coaching, feedback and assisting in conflict resolution 

• Ability to manage multiple concurrent projects and to deliver results accurately and on time 

• Strong organizational and problem-solving skills 

• Entrepreneurial, creative and high-energy team player with the proven ability to balance competing priorities 

• Must be detail oriented, organized, and have ability to inspire others towards a quality minded culture 

• Must be capable of working independently to achieve project schedules and goals 

• Driven by a high degree of integrity, with cultural and core value alignment to Creation 

• Strong learning mindset