The Sr. Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The individual will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. The individual will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business and supervise, lead and mentor other engineers and technicians.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close).
• Work with third party supplier to resolve issues with NC.
• Conduct Internal/Supplier Audits of the facility per ISO-13485 and/or 21CFR820
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk, including FMEA activities.
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

It is also understood that an associate may receive special projects outside of this list.

Aid in planning, conducting and reviewing validation activities.

SKILLS & COMPETENCIES

• Engineering or Technical degree with 5+ years of experience, or equivalent education and years of management experience OR Master degree with 3+ years of experience or equivalent education and years of experience
• Demonstrate excellent organizational and English communication skills (oral & written)
• Financial acumen relating to operations profit & loss (P&L) items,. Including ERP systems (Oracle ideal)
• Proficiency in MS Office Suite and statistical analysis software.
• Experience with writing and executing IQ/OQ/PQ documents
• Experience in working in an electronic QMS system (Trackwise preferred).
• Experience in regulated environment; medical device or pharma preferred
• Familiarity with health, safety, and environmental regulations related to manufacturing.
• Experience in regulated environment; medical device or pharma preferred
• Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.

Salary Pay Range:

$81,650.00 - $112,700.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

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