Senior Quality Engineer
Pleasanton, CA 94566 US
Target PR Range: 38-42/hr
*Depending on experience
This role is responsible for quality support for manufacturing, servicing, and warehousing of manufactured products. The Quality Engineer III will coach manufacturing quality personnel on GMP and SOP compliance and empower them to identify and escalate quality issues, to ensure overall quality of the product. This position is for a (medical device) site located in Pleasanton, California.
Essential Duties and Responsibilities include the following (other duties may be assigned):
· Responsible for providing quality support for New Product Introduction (NPI) for organization manufactured products
· Responsible for driving continual process improvements in responsible areas of the business utilizing tools such as SPC, Statistics, DOE.
· Review and approve changes made to product and processes and validation/qualification protocols and reports utilizing expertise in electronic change management systems, test method validations (TMV), V&V activities, IQ/OQ/PQ and mathematical concepts such as probability and statistical inference.
· Drive quality and manufacturing improvements to assure that processes are in a state of control
· Develop and maintains effective relationships and integrate activities with other departments and suppliers (as needed).
· Review and approve changes made to product and processes and validation/qualification protocols and reports
· Responsible for drafting and/or updating Quality Procedures for Quality Operations functions
· Initiate and develop standards and methods for inspection, testing, and evaluation as necessary. Assure product compliance to specifications through implementation of inspection criteria, procedures, and training.
· Establish and maintain quality metrics.
· Identify and lead projects and initiatives to improve the quality system.
· Perform internal audits and other related duties as assigned.
· Bachelors degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred
· Minimum of 7+ years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
· Proficiency in reading and interpreting mechanical drawings and GD&T.
· Knowledge of QSR and ISO 13485.
· Medical Device Auditor certification preferred.
· Problem solver.
· Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
· Knowledge of quality/continuous improvement tools (SPC, Statistics, DOE, Six Sigma) preferred
· Good oral and written communication skills.
· Ability to write reports, data analysis, and business correspondence.
· Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
· Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.
· Ability to work with mathematical concepts such as probability and statistical inference.
· Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
· Ability to use MS Excel to perform calculations and interpret results/data.
· Ability to define problems, collect data, establish facts, and draw valid conclusions.
· Ability to read technical literature and documents and extract important concepts.
· Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements.
· Knowledge of SAP ERP system preferred
Language and Verbal Skills:
Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Analytical and Reading Skills:
Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.