Quality Associate II

• Own / Approve various Quality System Records
• Responsible for conducting nonconformance root cause investigation, containment, correction, Field Action, corrective/preventive action, verification of effectiveness and closure activities
• Identify, implement, and monitor process improvements to ensure continuous improvement to product and process quality
• Mentor/coach Investigation Owners in developing investigation plan and results
• Monitor Quality System related activities to ensure timeliness of completion
• Verify respective functional activities for Quality System records are complete
• Compile & present information to facility (Medina Plant) and external (i.e. Medina Design Center) CAPA Review Board. Maintain CRB information per established requirements, as needed
• Develop and provide training as needed. Assist with Quality System Account Request Management
• Generate weekly nonconformance reports, as needed
• Participate in Audit readiness activities. Assist with / participate in Internal Audits, Corporate Audits, External Audits, as needed
• Complete Global Observation Certification reviews and Quality Alert reviews, as needed
• Provide support to the Change Control Management process by serving as a Quality Assessor

• Bachelor’s of Science in a science related field is required
• 2+ years’ experience in quality with a medical device/pharmaceutical company or similar regulated industry, preferred
• Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, ISO 13485, preferred
• Strong knowledge of risk management, root cause analysis, corrective and preventive action and document control
• Demonstrated use of quality and root cause analysis tools, principles, and methodologies including statistical tools
• Be able to author procedures in response to corrections or corrective actions
• Have computer proficiency with experience in Microsoft Word, Excel, and Access or other database programs
• This role requires extensive personnel interaction, including all functions and all levels of the organization
• Must have computer proficiency
• Ability to work effectively as part of a cross functional team
• Excellent organizational skills
• Excellent presentation skills
• Attention to detail
• Ability to multi-task and work well under pressure
• Understand scientific strategies and be able to invent new methods or new avenues of investigation
• Good interpersonal/communication/influencing/negation skills
• Good project management skills
• True understanding of FDA Regulations, Application of Good Laboratory Practices, and Good Manufacturing Practices
• Be able to stand, sit and walk throughout the work day

Trackwise proficiency and experience is a plus

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• Medical and dental coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP)
• 401(k) Retirement Savings Plan (RSP)
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits