Senior Quality Engineer

Creation Technologies•Dallas, TX

17d

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. 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 R eadily 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 m aintena nce 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 a ssists with resolving supplier performance issues Supports with training needs as , providing guidance and coaching to QEs , and r esponsible 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

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
Working knowledge and comprehension of quality management systems, measuring techniques, tools and equipment
Strong technical skills required including electronics and electro-mechanical principles
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
A Degree in Engineering or related technical discipline, and/or a combination of education and experience is
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

Nice To Haves

Work experience in a cGMP FDA 21 CFR Part 820, AS9100, AS9102 and ISO 14001 environment is strongly desirable
Experience in a PCBA low volume high mix or PCBA NPI desired
Experience in the application of Lean and Six Sigma Methodologies – CSSGB or CSSBB desirable
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
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 m aintena nce 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 a ssists with resolving supplier performance issues
Supports with training needs as , providing guidance and coaching to QEs , and r esponsible 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