What are the responsibilities and job description for the Medical Device Manufacturing Engineer position at inSync Staffing?
Job Title : Medical Device Quality Engineer
Starting Pay : $115 - $120k annual salary
Direct Hire
PURPOSE OF JOB : Highly motivated and detail-oriented Quality Engineer with experience in both engineering and manufacturing quality processes. This role will focus on ensuring product compliance, process improvement, and quality assurance throughout the manufacturing lifecycle. The ideal candidate will collaborate closely with engineering and production teams to identify and resolve quality issues, implement best practices, and drive continuous improvement initiatives .
MAJOR DESCRIPTION AND RESPONSIBILITIES :
Primary Job Responsibilities :
o All the job functions of Quality Engineer II
o QE representative for Development projects
o Participant in development of the DFMEA and PFMEA
o Provide guidelines to ensure Protocols and Reports meet internal and external requirements
o Act as a mentor on quality assurance and quality systems application within the department and across departments.
o Assist in the development and implementation of quality systems
o Project leader on various projects
o Provide, train, and perform statistical analysis and design of experiments
o Develop inspection process
o Practical applications of geometric dimensioning and tolerancing to drawings
o Train others and groups on Quality Assurance applications and Quality systems
Secondary Job Responsibilities :
o Provides lab support including culture media preparation and qualification, lab equipment calibration and maintenance, and culture maintenance, and maintaining lab supplies
o Interfaces with outside testing laboratories and representatives from other departments, and maintains testing results
o Monitor Pre-Production Quality Assurance Program
o Assist with Employee Quality System Training Programs
o Promote innovative practices that ensure quality, simplicity, and success in asserted company efforts
o Provides lab support including culture media preparation and qualification, lab equipment calibration and maintenance, and culture maintenance, and maintaining lab supplies
o Interfaces with outside testing laboratories and representatives from other departments, and maintains testing results
o Monitor Pre-Production Quality Assurance Program
o Assist with Employee Quality System Training Programs
o Promote innovative practices that ensure quality, simplicity, and success in asserted company efforts
EDUCATION AND REQUIREMENTS :
o 4 year technical or science degree
o Electronic experience a plus dealing with printed circuit board manufacturing
o Project management skills
o Understanding of statistical concepts including hypothesis testing, DOE, and sampling plans
o Understanding of metrology applications
o Understand Geometric Dimensioning and Tolerance applications and be able to apply concepts
o Working knowledge of Microsoft Office applications including Word, Viso, and Project
o SolidWorks experience a plus
EXPERIENCE REQUIREMENTS :
o 3-6 years of Quality / Regulatory experience in a medical device or other regulated industry
o Demonstrated knowledge of 21 CFR Part 820 QSM / ISO 13485 Quality Management System Requirements
o Demonstrated skills at development and implementation of Quality System components
o Implemented quality systems
o Lead project teams
o Highly developed written and oral communication skills and be able to work in a team environment
o Must have good problem solving skills and be able to work independently
o Medical / Pharmaceutical Statistical Application Experience a plus
OTHER QUALIFICATIONS :
o Travel approximately 15%
o Lab
o Biohazard
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants : Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act
IND02
Salary : $115,000 - $120,000
