Quality Assurance & Regulatory Affairs Manager

Job 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. 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

Medical Murray is an equal-opportunity employer.