A global medical device company in Irvine, CA, has an exceptional opportunity for Sr. Engineer
within the Supplier Quality
group. This person will be responsible for supporting supplier quality vendor management, audits, and improvements while supporting continued Quality System improvements. The Sr. Engineer
will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and company's systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.Key responsibilities:
• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop, update, and maintain technical content of risk management files
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Train, coach, and guide lower level employees on routine proceduresSkills:
• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Working knowledge and understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Education & Experience:
• Bachelor's Degree or equivalent in Engineering with 4 years related industry experience required, or
• Master's Degree or equivalent in Engineering with 3 years related industry experience required, or
• Ph.D. or equivalent in in Engineering
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Business Process Improvement
Complex Problem Solving