Quality Engineering Senior

Senior Quality Engineer

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.

Responsible for In Process Quality Controls, day to day quality performance in manufacturing (e.g. 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

Develops customer specific quality plans

Supports Site Quality Leader in regulatory, customer and internal audits

Executes the internal quality audit program

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

Minimum of 5 years' experience in a manufacturing environment as a quality engineer or equivalent

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

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

Seasoned at providing coaching, feedback and assisting in conflict resolution

Ability to manage multiple concurrent projects and to deliver results accurately and on time

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

All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

If you require any accommodations to complete the application process or need the job posting in an alternative format, please email View email address on click.appcast.io for the position will be in accordance with applicable national and local laws.