Quality Assurance & Regulatory Affairs Manager

Position Summary:

Reporting to the Director of Quality Assurance & Regulatory Affairs, The Quality Assurance and Regulatory Affairs Manager position performs management duties in the quality department in support of the department objectives (both Production and R&D related) to provide goods and services that meet customer’s requirements for quality, quantity, and timeliness. The position’s responsibilities pertain to compliance with quality systems and regulatory-related activities. The QA/RA Manager oversees the quality staff at their site and assigns work.

Essential Duties and Responsibilities:

• Provide guidance and training to employees on internal and external quality and regulatory standards and requirements
• Manage the local production quality team and ensure products manufactured meet specifications and customer quality requirements
• Manage the local R&D quality team to ensure project deliverables and products meet specifications, customer quality requirements, and applicable regulatory requirements
• Identify and manage site needs for quality resources to meet objectives
• Ensure production inspections are completed to meet delivery objectives and that processes are maintained with updated work instructions and forms as necessary
• Ensure timely processing of materials through quality processes
• Maintain site-specific quality metrics reporting system, ensure that quality metrics data are identified and monitored, periodic trend reports are distributed to management personnel
• Oversee review and approval of Lot History Records and sterilization activities and paperwork
• Oversee risk management activities compliant with ISO 14971
• Review components, products, and processes for optimization of inspection method, sampling plan, and documentation
• Manage the customer complaint process for R&D and evaluate returned product
• Support validation and verification activities
• Supervise and manage the quality staff, including training, performance appraisals, periodic 1:1 meetings, and assigning work
• Manage selection and hiring of personnel, in accordance with company policies with support from the department Director
• Assist in maintaining, implementing, and updating the Quality Management System
• Manage site Material Review Board
• Perform internal audits and represent the company during external audits for FDA, Notified Bodies, and customers
• Oversee employee performance including disciplinary action (discipline in conjunction with HR)
• Support team in resolving project issues and customer escalations

Minimum Qualifications:

• BS or MS in technical, life sciences, or engineering discipline
• Knowledge and understanding of ISO-13485, ISO-14971, and FDA 21 CFR Part 820 cGMP standards
• Professional certification of ASQ or similar body preferred
• Proven leader that can embrace and promote change in a dynamic environment
• Ability to lead a group and promote employee engagement and proper allocation of department resources
• Medical device quality experience is mandatory
• Quality assessment/audit experience
• 5 or more years in Quality Engineering or Quality Management for medical devices preferred
• Supervisory experience
• Experience in both production and R&D environments strongly preferred

Knowledge, Skills, Abilities:

• Ability to organize and coordinate work efficiently, set priorities, and motivate others
• Possess a high energy level, attention to detail, and sense of urgency
• Microsoft Office Suite skills
• Strong analytical and problem-solving skills
• Strong customer orientation with excellent written and verbal communication skills
• Ability to manage time and self to meet organizational objectives
• Hands-on and multi-tasking skills

For Your Benefits:

• Competitive salary
• Medical insurance (BCBS): Eligible on first day of employment
• HSA-eligible medical plans
• Dental insurance
• Company-paid employee vision, Life, and Long and Short-Term Disability insurance
• 401k safe harbor retirement plan (3% employer contribution annually)
• 23 days of Paid Time Off
• Voluntary Life
• TeleDoc program
• Identity protection
• Tuition Reimbursement
• Paid time off for community outreach and volunteering

About Medical Murray:

Since 1996, Medical Murray has been a privately owned company producing finished medical devices, components, and subassemblies for customers around the world ranging from startups to the largest OEMs. We specialize in the development, testing, and manufacturing of permanent implants, delivery systems, and complex catheters for vascular, gastrointestinal, urologic, and other interventional markets. Our core goals are Integrity First, People Matter, First Class Service, Inspired Innovation, and Community Service. To learn more, please visit us at www.medicalmurray.com

Medical Murray is an equal-opportunity employer.