Quality Engineer

Job Juncture; Plano (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Job Juncture is seeking a Senior Quality Engineer in Plano, TX to ensure day-to-day compliance with quality and regulatory standards. This role leads QE staff and reports to the Site Quality Leader, driving quality improvements across processes and supplier quality operations.

The successful candidate will have strong technical electronics knowledge, ISO/IEC experience, and a track record in facilitating audits, CAPA resolution, and NPI support within a manufacturing environment.

Qualifications

• Minimum 5 years in manufacturing as a quality engineer or equivalent.
• Working knowledge of ISO 9001 and 13485.
• Experience in cGMP FDA 21 CFR Part 820, AS9100, AS9102 and ISO 14001 desirable.
• Strong technical skills in electronics and electro-mechanical principles.
• Experience with PCBA low volume/high mix or PCBA NPI desired.
• Knowledge of SPC, implementation and reporting.
• ASQ CMQ/OE, CQE or CQA certifications desirable.
• Degree in Engineering or related technical discipline required.

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

Skills

MS Office proficiency

Leadership

Analytical problem solving

Process improvement

SPC knowledge

Lean Six Sigma

GMP knowledge

Auditing

ISO standards knowledge

Regulatory knowledge

Education

Engineering degree

Job description

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

• 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

Additional duties

• 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

Quality Management

• Assist Site Quality leader to maintain and improve QMS
• Ensure conformance to quality and environmental certifications and standards (ISO, IPC, etc.)

Supplier Coordination

• Coordinates with Regional Supplier Quality Engineer to resolve supplier performance issues

Training & Audits

• 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

QUALIFICATIONS

• 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

• ASQ CMQ/OE, CQE or CQA certification highly desirable

SKILLS 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