Sr. Quality Engineer

Creation Technologies•Dallas, TX

About The Position

It'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.

Requirements

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
Highly proficient in MS Office Word and PowerPoint with advanced knowledge in Excel
Ability to make judgement 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 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

Nice To Haves

ASQ CMQ/OE, CQE or CQA certification highly desirable

Responsibilities

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
Manage complaint/NCR database and address Customer issued SCARs
Responsible for performing qualifications based on customer requirements
Supports NPI process for new products
Develops customer specific quality plans
Supports Site Quality Leader in regulatory, customer and internal audits
Executes the internal quality audit program
Leads and trains cross functional teams to perform layered process audits
Assist Site Quality leader to maintain and improve QMS
Ensure conformance to quality and environmental certifications and standards (ISO, IPC, etc.)
Coordinates with Regional Supplier Quality Engineer to resolve supplier performance issues
Supports training needs as required, providing guidance and coaching to quality and production team
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
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
Keeps Site Quality Leader fully apprised of significant occurrences and trends that impact the quality of processes, quality systems or supplier quality operations