Quality Engineer

I, John Myers, have been in this factory several times over the past 30 years. It is a great company and factory. The company has a great culture and ex-employees have no complaints. :) If you have more questions don't hesistate to contact us. Linkedin is the best way to message John or Michael, company page StepBeyond Solutions Inc or go to StepBeyond.com to contact or apply too. --------CREATION JOB DESCRIPTIONIt's fun to work in a company where people truly BELIEVE in what they're doing!We're committed to bringing passion and customer focus to the business.The Senior Quality Engineer ensures day to day compliance with applicable quality and regulatory standards. This position indirectly provides leadership to the Quality Engineering Support personnel within the site. The successful candidate will report directly to the Site Quality Leader.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 approachesReadily available to solve real-time manufacturing qualityManage complaint/NCR database and address Customer issued SCARsResponsible for performing qualifications based on customer requirementsSupports NPI process for new productsDevelops customer specific quality plansSupports Site Quality Leader in regulatory, customer and internal auditsExecutes the internal quality audit programLeads and trains cross functional teams to perform layered process auditsAssist Site Quality leader to maintain and improve QMSEnsure conformance to quality and environmental certifications and standards (ISO, IPC, etc.)Coordinates with Regional Supplier Quality Engineer to resolve supplier performance issuesSupports training needs as required, providing guidance and coaching to quality and production teamCoordinates and conducts frequent cell level process layered audits with QE personnel and other site functional leadersAssists with regional and site quality initiative projectsSupports and assists other Quality Engineers in the Customer Focused Team for systemic issues and CAPA resolutionManages and collects systemic data for process improvementSustains knowledge of quality and regulatory changes applicable to their manufacturing siteKeeps Site Quality Leader fully apprised of significant occurrences and trends that impact the quality of processes, quality systems or supplier quality operationsQUALIFICATIONS:Minimum of 5 years’ experience in a manufacturing environment as a quality engineer or equivalentDemonstrated working knowledge of ISO 9001 and 13485 standards is requiredWork experience in a cGMP FDA 21 CFR Part 820, AS9100, AS9102 and ISO 14001 environment is strongly desirableWorking knowledge and comprehension of quality management systems, measuring techniques, tools and equipmentStrong technical skills required including electronics and electro-mechanical principlesExperience in a PCBA low volume high mix or PCBA NPI desiredKnowledge of Statistical Process Controls (SPC), implementation and reportingAbility to lead problem solving activities with site level teams executing effective corrective actionsFamiliarity with inspection practices and solder knowledgeExperience in the application of Lean and Six Sigma Methodologies – CSSGB or CSSBB desirableA Degree in Engineering or related technical discipline, and/or a combination of education and experience is requiredASQ CMQ/OE, CQE or CQA certification highly desirableSKILLS REQUIRED:Highly proficient in MS Office Word and PowerPoint with advanced knowledge in ExcelAbility to make judgement calls on material conformanceFamiliarity with IQ/OQ/PQExcellent communication and interpersonal skills adaptable to all levels of the organizationSeasoned at providing coaching, feedback and assisting in conflict resolutionAbility to manage multiple concurrent projects and to deliver results accurately and on timeStrong organizational and problem-solving skillsEntrepreneurial, creative and high-energy team player with the proven ability to balance competing prioritiesMust be detail oriented, organized, and have ability to inspire others towards a quality minded cultureMust be capable of working independently to achieve project schedules and goalsDriven by a high degree of integrity, with cultural and core value alignment to CreationStrong learning mindset