Quality Assurance Engineer III
1 month ago
POSITION SUMMARY:
- This position is accountable for development, implementation, evaluation, and support of quality system activities for their assigned plant.
- Manage specific aspects of the quality and product safety management systems including internal audit, calibration, nonconforming material control, inspection and test, and others as assigned by the Plant Quality Manager
- Prepare appropriate quality-related reports as assigned by the Plant Quality Manager.
- Represent the company in a professional manner when interacting with suppliers, customers, and internal stakeholders.
ESSENTIAL DUTIES:
- Manage internal audit program, including development of annual audit schedules, conducting audits, and assigning auditors, evaluating, and tracking audit reports and findings, initiating and following-up on corrective actions.
- Ensures regulatory requirements like 21 CFR Part 820, MDSAP, ISO 13495, EU MDR, MDD are met.
- Participate in new product qualifications and validations to ensure quality, product safety and regulatory requirements are addressed pre-production.
- Participate in customer complaint and NCM investigations and other problem-solving efforts. Assist in measuring/collecting product and process data/information necessary to determine or validate root causes and permanent corrective actions.
- Technical lead for inspections which includes defining methods and qualifying the method (TMV, Gage R&R)
- Programming optical/vision-based measurement systems like MicroVu, Keyence etc.
- Lead process automations like paperwork reduction, Quality 4.0 initiatives, Electronic QMS implementation.
- Utilizing lean and six sigma tools to improve internal manufacturing and non-manufacturing processes.
- Defines and implements quality system processes and procedures.
- Understands all aspects of assigned production line(s) to help minimize scrap and complaints.
- Implements corrective actions and uses CAPA system to consistently improve product quality.
- Prepares written protocols and reports.
- Performs a variety of complex tasks using experience and judgment.
- Mentor junior level team members.
- May lead and direct the work of others in various projects and assignments.
- Upholds Xeridiem vision and core values.
- Performs other duties as required.
QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)
Required:
- Bachelor's degree or higher in Engineering (Mechanical/Industrial/Engineering Management/Biomedical/Electrical)
- 7 + years of industry experience in a similar role
- Has knowledge of commonly used concepts, practices, and procedures within the field, including regulatory affairs.
- Ability to problem solve, identify errors and deficiencies and perform research independently
- Ability to apply knowledge to their job function using pre-established guidelines and instructions
- Accuracy, attention to detail, and thoroughness
- Proficient in computer skills and ability to use MS office, Minitab etc.
- Proficient communications skills
- A wide degree of creativity and latitude
- Ability to comprehend and comply with company safety and quality standards
- Ability to follow oral and written instructions
Preferred:
- Previous experience in Quality Assurance
- Rudimentary knowledge of statistics
- Medical device experience
- Certified Quality Engineer (CQE)
- Lean Six Sigma Green Belt or Black Belt
WORKING CONDITIONS:
This position requires about 50% of time spent sitting and working on computer. The other 50% of time would be spent moving around on the Production floor where protective clothing is necessary.
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