Sr. Quality Engineer

The Senior Quality Engineer ensures day‑to‑day compliance with applicable quality and regulatory standards and provides indirect leadership to Quality Engineering Support personnel. The successful candidate reports directly to the Site Quality Leader. Duties / Responsibilities Responsible for in‑process quality controls and 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. Manage complaint/NCR database and address customer‑issued SCARs. Perform qualifications based on customer requirements. Support NPI processes for new products. Develop customer‑specific quality plans. Support the Site Quality Leader in regulatory, customer, and internal audits. Execute the internal quality audit program. Lead and train cross‑functional teams to perform layered process audits. Assist the Site Quality Leader to maintain and improve the QMS. Ensure conformance to quality and environmental certifications and standards (ISO, IPC, etc.). Coordinate with the Regional Supplier Quality Engineer to resolve supplier performance issues. Support training needs, providing guidance and coaching to quality and production teams. Coordinate and conduct frequent cell level process layered audits with QE personnel and other site functional leaders. Assist with regional and site quality initiative projects. Support and assist other Quality Engineers in the Customer Focused Team for systemic issues and CAPA resolution. Manage and collect systemic data for process improvement. Sustain knowledge of quality and regulatory changes applicable to the manufacturing site. Keep the Site Quality Leader fully apprised of significant occurrences and trends that impact quality 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 ISO 13485 standards. 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 in electronics and electro‑mechanical principles. Experience in 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 with Lean and Six Sigma Methodologies – CSSGB or CSSBB desirable. A degree in Engineering or a related technical discipline, and/or a combination of education and experience. ASQ CMQ/OE, CQE, or CQA certification highly desirable. Skills Required Highly proficient in MS Office Word, PowerPoint, and advanced knowledge in Excel. Ability to make judgment calls on material conformance. Familiarity with IQ/OQ/PQ. 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 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. Detail‑oriented, organized, and able to inspire others towards a quality‑minded culture. 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. Creation Technologies is an equal‑opportunity/affirmative‑action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. #J-18808-Ljbffr Creation Technologies International Inc