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Quality Assurance - Charlotte, United States - Medical Murray
Description
Job DescriptionJob Description
The wage range for this position is $100,000 to $120,000. Compensation decisions are dependent on the specific details and circumstances of each candidate such as experience, skills, and education. Therefore, job title and salary range may vary.
Title:
Quality Assurance & Regulatory Affairs Manager
Location:
Charlotte, NC (Onsite Position)
Some relocation assistance may be available
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.
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 atMedical Murray is an equal-opportunity employer.
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