Supplier Quality Engineer

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Role: Supplier Quality Engineer

Location: Warsaw, IN

Duration: 12+months

Responsibilities

• Review supplier pFMEAs, manufacturing control plans, process validation/verification to ensure compliance with internal procedures

• Experience in Design of Experiment (DOE), Process Optimization, lean manufacturing, new product deliverables to production, quality control and quality assurance, reliability engineering testing.

• Experience with ISO 13485, FDA 21 CFR Part 820, FMEAs, DMAIC, statistical DOE, work methods, tool procurement & qualification

• Perform Gage R&R studies and analysis

• Supplier Parts inspection and quality control

• Blueprint literacy including GD&T for part inspection

• Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA

• Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.

• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing including Suppliers

• EDUCATION & EXPERIENCE REQUIREMENTS :

• A minimum of Bachelor's degree in engineering or related technical or scientific discipline with a minimum of 5 years of experience in related field are required.

• Strong design/quality engineering skills with a proven track record in all aspects of the new product design control process including supplier quality

• Proven track record implementing Quality System improvements to meet compliance and overall business goals

• Change control experience (reviewing and approving design engineering change orders through a PLM System) is required

• Candidate should possess excellent problem solving, decision-making, and root-cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.

• Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers.

• Working knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred.

• Previous experience in a medical device or a healthcare discipline is required

• Previous Supplier Quality Engineering experience is preferred

• Development and/or manufacturing experience is preferred.

• Knowledge of process and design excellence tools is preferred.