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 coaching and mentorship 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
- 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:
- A Degree in Engineering or related technical discipline, and/or a combination of education and experience is required
- Minimum of 7 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
- 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
WORKING ENVIRONMENT:
Physical Demands
- The incumbent must be able to safely maneuver around the facility
Mental Demands
- Emotionally capable of professionally handling high-pressure situations in a fast paced, highly demanding industry
- Capable of excelling in quality investigation type situations where listening and collaborating are essential to determine next steps and solutions
Working Conditions
- Equal mix of office and production environment. Available for quality support to 2nd shift as needed.
- You will be required to wear safety clothing and gears when working in safety sensitive environments
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.
Canada: Title for the position will be in accordance with applicable national and local laws.
