Senior Quality Engineer

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Think differently and challenge what's possible.

Responsibilities

• Support quality improvement initiatives such as process and product characterizations leading to continuous / cost improvements.
• Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close).
• Work with third party suppliers 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.
• Escalate quality issues as appropriate.
• Achieve 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.
• Aid in planning, conducting and reviewing validation activities.

Requirements

• Engineering or Technical degree with 5+ years of experience, or equivalent education and years of management experience.
• 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.

Qualifications

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)).

Skills & Competencies

• Engineering or Technical degree with 5+ years of experience, or equivalent education and years of management experience.
• Master degree with 3+ years of experience or equivalent education and years of experience.
• 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.

Benefits

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

Pay

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 training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.