|Employer Name: EIR Network
|Location: Bradenton, Florida
||Date Posted: 9/4/2019
|Number Of Openings: 1
The primary job responsibility for the Quality Engineer is for ensuring the compliance of the manufacturing process(es) and directly supporting overall quality initiatives within the organization. This is included but not limited to:
Development and execution of developing test methods, write protocols, perform DOEs - execute testing, and performing MINITAB analysis of results, evaluate design stability and capability, and preparing test reports.
Ensuring conformance of all phases of a products lifecycle in an FDA and ISO regulated medical device environment.
Implementing/improving statistical proess control techniques.
NC/CAPA/Complaint Investigation and MRB participation, or management.
Risk Management (dFMEA/pFMEA) active team member.
This role will promote customer advocacy (both internal and external) using a verity of training and motivational tools while communicating throughout all levels of the business. Communications must include the linkage between projects and desired business results, and reinforce working with manufacturing partners to eliminate process variation key to business improvement and profitability. In addition, they are responsible for coordinating resolution of lower level issues by leading teams from all areas of Manufacturing, Engineering, Purchasing, Supply Chain, and Technical Resources.
Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.
Works closely with senior QA Engineers, R&D, Design Engineering, and contributes in developing quality specifications for new products.
Active team member during risk assessment activities and updates associated dFMEAs and pFMEAs as required.
Develops test methods, write protocols, perform DOEs, execute testing, and perform MINITAB analysis of results, evaluate process stability and capability, and prepare test reports.
Assists with the development of new tooling prototypes, identifies and assumes responsibilities for storage of the engineering samples.
Performs essential measurements, testing, analysis, and keeps records using Good Documentation Practices and communicates to team about findings.
Supports process validation activities associated with both new and/or changed products, and maintains all associated supporting documentation for engineering protocols and reports.
Assists with mechanical design for quality gages and fixturing.
Supports reliability analysis, problem solving and continuous improvement activities.
Contributes in preparing and updating quality plans, as required.
Assists in preparation and updates of manufacturing procedure documentation, and quality procedure documentation.
Maintains revisions of process specifications as required.
Assists in the analyses of Non-conforming product/processes and complaint data analysis.
Assists in root cause investigations, and provides input to appropriate abatement activities.
Maintains NCE / CAPA documentation in a timely manner.
Participates in process improvement activities within the business to drive consumer satisfaction levels and business productivity.
Supports the implementation of new/updated manufacturing processes.
Drives a culture of continuous improvement and identifies actions to eliminate process variation.
Participates in assessment teams in applying quantitative tools to identify the current state from which improvement opportunities exist.
Communicates project progress, capture cost savings, consumer satisfaction, or other appropriate business productivity metrics to direct supervisor.
Documents data obtained during all quality activities using good documentation practices.
Communicates significant issues or developments identified during quality activities and provides recommended process improvements to senior QA engineers and/or direct supervisor.
Identifies and proposes continuous improvement opportunities to senior QA engineers.
Initiates corrective and preventive action (CAPA) plans with root cause analyses as needed.
Performs other duties as needed.
Bachelor Degree in Science, Engineering or similar
Required Knowledge, Skills, and Abilities:
Minimum 2 years full time experience in a Quality engineering role
One (1) year of practical medical device manufacturing experience is preferred.
General knowledge of FDA, cGMP and ISO Standards/regulations.
Good working knowledge of upstream process development and validation experience, including protocol development.
Able to read and interpret mechanical drawings
Test method development and documentation
General knowledge with ASTM methods
General knowledge of Six Sigma methodology, SPC techniques and MINITAB data analysis
Microsoft windows applications: power point and Visio
Organization and analytical skills
General knowledge of lab equipment, instruments and calibration procedure
Ability to work in a cross-functional team setting
Detailed oriented, high energy, self-starter, who exercises sound judgment and deliver against company business goals and objectives
Excellent communication, and presentation skills, both orally and written.
Results oriented change agent
Ability to read, write and communicate in English.
Ability to speak Spanish a plus
Position Type: Full-Time Permanent
Years of Experience Required: 2
Education Required: Bachelors
Overnight Travel: None
Vacation Time: 2 weeks / year
Health/Dental Benefits, Retirement Benefits, Paid Holidays, Vacations, and Sick Leave, Life and/or Disability Insurance, Relocation Assistance, Casual Dress
Web Site: https://eirnetwork.com
|Contact Name: Max Sabrin
||Company Type: Recruiter
|Company: EIR Network
|City: Old Saybrook