10% Travel

• Should be able to handle stress and pressure at times
• 8+ years of quality engineering and/or operations experience including a minimum 5 years’ experience in an electro-mechanical, assembly and test manufacturing environment.
• Team player
• Design Control and/or Design Assurance experience
• Risk management
• Supplier Development and Management experience.
• change control
• Risk management exp
• Development of Master Validation Plan, Quality Plans and Reports
• GMP
• Background in medical device products
• Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufacturing process readiness. Support and/or drive Equipment and Process Validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (OQ), internally or externally.
• ISO 13485, ISO 14971
• Design history files, master record
• Design transfer process
• Documentation control
• Design history file / design master record
• Coordinate team in variosu projects
• Pharma or aerospace or medical device industry exp will work
• Should be able to work in fast paced environment
• 15 yrs of exp will also work

Top Skills

• Design Control and/or Design Assurance experience
• Supplier management
• Documentation control

Not looking for candidates willing to relocate. Onsite interview required.

• 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 Coolsculpting (medical device) site, located in Pleasanton, California.

Essential Duties and Responsibilities include the following (other duties may be assigned):

• Participate in design reviews, Risk Management, Validation & Verification plans and reports during Product Development as required.
• Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufacturing process readiness.
• Support and/or drive Equipment and Process Validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (OQ), internally or externally.
• Development of Master Validation Plan, Quality Plans and Reports
• Provide quality inputs and/or requirements as applicable.
• Focuses and determines proper engineering principles on reliability issues.
• Drive and own quality assurance and requirements during development phases and post-market release, including Change Control
• Implement lessons learned in other/new products, respectively new or running projects.
• Identify and manage Critical to Quality (CTQ’s)
• Adhere to defined and communicated Corporate Quality requirements, applicable Regulatory Standards, methods, and procedures, with openness to identifying improvements.
• Focus on streamlining activities for increased efficiencies.
• Control of Documentations

Qualifications:

• Bachelor’s degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred.
• Demonstrated competency with desired 8+ years of quality engineering and/or operations experience including a minimum 5 years’ experience in an electro-mechanical, assembly and test manufacturing environment.
• Proficiency in reading and interpreting mechanical drawings and GD&T.
• Medical Device Auditor certification preferred.
• Certified Six Sigma Black Belt, Green Belt or Lean Master preferred with proven completion of projects in which solutions were sought at the root level of the problem.
• Supplier Development and Management experience.
• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO 13485, ISO 14971, and all other international regulatory requirements with which CLIENT complies.
• Design Control and/or Design Assurance experience
• Excellent analytical skills.
• Experience working in cross-functional, cross-business and cross-cultural projects.
• Hands-on personality.
• Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
• 10% Travel

Language and Verbal Skills:

• Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

Math Skills:

• 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.

Physical Requirements:

• 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.

Work Environment:

• Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.

Job Type: Contract

Salary: $50.00 - $60.00 per hour

Schedule:

• 8 hour shift
• Day shift

Ability to commute/relocate:

• Pleasanton, CA 94566: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Risk management: 8 years (Preferred)
• quality engineer: 8 years (Preferred)
• Design Control and/or Design Assurance: 8 years (Preferred)
• change control: 5 years (Preferred)
• IQ OQ PQ: 8 years (Preferred)
• Documentation control: 7 years (Preferred)
• Supplier management: 8 years (Preferred)
• pharma or medical device industry: 8 years (Preferred)

Work Location: One location

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