Quality Engineer

This Jobot Job is hosted by: Amber Wood
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Salary: $75,000 - $100,000 per year

A bit about us:

Manufacturer of Medical products

Why join us?

Competitive Compensation
Full benefits
Growth Opportunities

Job Details

Bachelor's degree in a related engineering field such as mechanical, industrial or chemical is required with 4+ years in a Quality Engineering role
At least 4+ years validation experience in a manufacturing environment
Experience with ISO 13485
Ability to independently apply analytical skills, complex scientific technical principles and detailed knowledge in solving engineering problems
Clear understanding and application of DOE, DFMEA and PFMEA methodologies
Experience with Statistical Process Control methods (control charts, CpK's, etc.) is required
Knowledge of Good Manufacturing Practices (GMP's) encompassing plastics extrusion lines, calculations of speeds, material composition understanding, comprehension of the basic function of fixtures and familiarity with inspecting and checking methods
Proficient in Gauge R & R metrology
Ability to read and interpret prints and tool designs
Ability to troubleshoot / solve problems independently or as part of a team
Excellent verbal and written communication skills
Ability to, internally and externally, discuss and clearly define key technical and process development issues and independently develop course of action / plans
Minitab or equivalent statistical software is required
Excellent computer skills including Microsoft applications
Must be hands on and willing to work in production environment including off shifts when projects require
Ability to travel to division and customer locations to support product and process related projects and quality concerns

Responsibilities
This position is responsible for supporting quality engineering activities
This includes participation in the development of new products and processes through commercialization, validation, change management and root cause investigations
Works with various departments to investigate customer complaints
Develops, modifies, applies and maintains quality standards and generates protocols and reports
Works directly with the quality technicians on product evaluations during the production process, analyzes data from inspection reports and resolves quality problems
Ensures production has the necessary documentation for production runs
Act in conjunction with Quality Manager as a technical contact on quality related issues for internal and external customers
Respond quickly to customer quality issues including performing investigations, apply root cause analysis and problem solving techniques to address concerns
Investigate and document customer non-conformances and corrective actions
Follow Lean Six Sigma (DMAIC) methodology to determine root cause of problems and implement sound corrective action
Development and implementation of quality system documentation and maintenance
Responsible for leading validation of new gauging equipment, new process equipment and products
Working knowledge of process flow maps / diagrams, control plans and measurement system evaluations in support of standard requirements
Assist in audits (internal and external) by third party registrars and / or customers and maintaining the ISO 9001 and ISO 13485 procedures and work instructions
All other duties as assigned

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Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.