Top 46 Quality assurance manager Jobs in Wake Forest, Nc

Mgr., Product Complaints (Hybrid)
Eisai —Raleigh, NC
- $104,900 - $137,700 a year
- Full-time
- Hybrid work
- 5 years
- Engineering
- Neurology
External Quality Operation Manager (GMP)
Sobi —Raleigh, NC
- $120,000 - $140,000 a year
- Full-time
- Hybrid work
- 5 years
- English
- Senior level
- Health insurance
Quick Apply
Quality Manager
Tekni-Plex —Clayton, NC
- $110,000 - $138,000 a year
- Engineering
- Mid-level
- Ability to lift 50 pounds
- Health savings account
- AD&D insurance
Quick Apply
Manager, Quality
LCI —Durham, NC
- Monday to Friday
- Engineering
- Analysis skills
- Travel
- Wellness program
- Paid holidays
Quick Apply
7d
Hub NAM Quality & Continuous Improvement Manager
Hitachi —Raleigh, NC
- Full-time
- Bachelor's degree
- Conflict management
- In-person
Hub NAM Quality & Continuous Improvement Manager
Hitachi Rail —Raleigh, NC
- Full-time
- Bachelor's degree
- Conflict management
- In-person
Quality Manager
PeopleShare —Durham, NC
- Call employer
- Spanish
- 3 years
- Master's degree
Quick Apply
Global Quality Manager
LINCOLN TECHNOLOGY SOLUTIONS, Inc. —Cary, NC
- $100,000 - $125,000 a year
- Full-time
- 7 years
- Management
- Analysis skills
- AD&D insurance
- Paid holidays
Quick Apply
Quality Control and Testing Manager
Siemens —Knightdale, NC
- $83,966 - $143,942 a year
- Full-time
- 5 years
- Engineering
- Team management
- Relocation assistance
Traveling Quality Assurance - Quality Control Manager - MSG - Pharmaceutical
Turner Construction Company —Raleigh, NC
- $120,000 - $217,000 a year
- Full-time
- Construction site
- 5 years
- Research
- Health savings account
- Disability insurance
Quality Control Manager (RTP)
EMCOR Government Services, Inc. —Research Triangle Park, NC
- $100,000 - $115,000 a year
- Full-time
- 5 years
- Project management
- Senior level
Senior Manager, Quality Assurance (OTC)
Revlon Corporate —Oxford, NC
- $105,000 - $130,000 a year
- Hybrid work
- 7 years
- Writing skills
- Bachelor's degree
- Paid holidays
- Disability insurance
GMDP Quality Assurance Manager
WEP Clinical —Morrisville, NC
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Paid parental leave
- Health savings account
Manager, Quality Risk
Grifols —Durham, NC
- Full-time
- Hybrid work
- Bachelor of Science
- Office
- Supervising experience
Principal Specialist, ERP S4 HANA Project Management Test Lead (Remote)
RTX Corporate —Raleigh, NC
- $86,800 - $165,200 a year
- Full-time
- 3 years
- Bachelor's degree
- Travel
- Paid holidays
- Loan repayment program
5d
Senior Manager, Quality Operations
Alcami Corporation —Morrisville, NC
- Full-time
- 7 years
- Ability to walk for extended periods
- Ability to lift 50 pounds
Validation Lead
Novartis —Durham, NC
- $126,000 - $234,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Doctor of Philosophy
- Health insurance
- 401(k) matching
QC Manager, Sample and Lab Equipment Management
Biogen —Research Triangle Park, NC
- $111,000 - $149,000 a year
- Full-time
- Supervising experience
- Bachelor's degree
- Recruiting
- Paid parental leave
- Employee stock purchase plan
Quality Manager (Regulated Industry)
Mentor Technical Group —Durham, NC
- Full-time
- Spanish
- Microsoft Outlook
- 5 years
Manager, Quality Management
Deloitte —Raleigh, NC
- $97,600 - $179,900 a year
- Full-time
- CPA
- 5 years
- Office
13d

I want to receive the latest job alert for quality assurance manager in wake forest, nc

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

quality assurance manager jobs near wake forest, nc

Mgr., Product Complaints (Hybrid)

Eisai -
Raleigh, NC

Apply Now

Job Details

Full-time
$104,900 - $137,700 a year

Qualifications

Content creation for technical audiences
Technical documentation
Technical writing experience within manufacturing
Quality risk management
Design usability
Biomedical regulatory compliance
Cross-functional collaboration
ISO 13485
Cross-functional communication
FDA regulations

Full Job Description

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

The Manager, Product Complaints is responsible for the oversight, governance, and continuous improvement of Eisai’s medical device complaint handling process. This role ensures that medical device complaints are consistently captured, appropriately triaged, thoroughly reviewed, and closed in compliance with FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR, and Eisai quality system requirements.
The role serves as the single point of entry for all Raleigh site commercial product complaints to ensure data quality and consistency; however, the position only triages and fully manages medical device complaints. This role is accountable for reviewing, challenging, accepting, and approving investigations from the device manufacturer on behalf of Eisai.
This role partners closely with medical information by providing high-quality medical device complaint data, accepted investigation outcomes, and trend analyses to support vigilance and signal management activities as part of the Post-Market Surveillance program (PMS).

Essential Functions:

Serve as the single point of entry for all Raleigh site product complaints, ensuring timely, accurate, and complete complaint documentation while following established Eisai procedures for routing all complaints.
Triage and classify medical device complaints, including confirmation of device involvement, user error considerations, and potential quality or safety impact.
Own and oversee the end-to-end lifecycle of medical device complaints, including intake, triage, investigation oversight, escalation, documentation, and closure. Apply human factors and usability engineering principles to assess whether events are attributable to user error, use related risk, foreseeable misuse, or product quality/design issues.
Manage complaint sample handling (shipping, tracking) to external sites for investigation.
Review investigation strategies, failure analysis methodologies, root cause determinations, and supporting evidence to ensure investigation adequacy, scientific rigor, and regulatory compliance.
Escalate inadequate, delayed, or non‑compliant investigations through Quality governance and supplier oversight mechanisms.
Establish and monitor medical device complaint metrics, dashboards, and trend analyses (e.g., failure mode, component, lot/batch, time to event).
Ensure complaint data effectively informs CAPA, risk management, and product improvement initiatives.
Author, own, and maintain SOPs related to Complaint Handling and Oversight
Drive continuous improvement initiatives related to complaint handling effectiveness, investigation quality, and compliance.

Requirements:

Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Pharmacy, or a related technical field.
5+ years of experience in medical device complaint handling, post market quality, or related quality system roles, required.
Medical Device (auto-injector) and combination product experience required.
Experience providing oversight of externally performed medical device investigations (e.g., CMOs or device manufacturers) preferred.
Hands‑on experience with complaint systems compliant with 21 CFR Part 820 (QMSR), ISO 13485, and EU MDR.
Prior involvement in medical device recalls or field actions preferred.
Strong knowledge of:
- FDA Medical Device Reporting (21 CFR Part 803)
- EU MDR vigilance and complaint handling requirements
- ISO 14971 risk management principles
- IEC 62366‑1 usability engineering

Strong cross functional collaboration and stakeholder influence skills.
Excellent organizational, time management, and technical writing capabilities.
Values aligned with Eisai’s mission and patient first culture, including integrity, professionalism, quality, and teamwork.
Ability to work a hybrid schedule (a minimum of 3 designated days - T, W, TH - onsite)

Eisai Salary Transparency Language:

The annual base salary range for the Mgr., Product Complaints (Hybrid) is from :$104,900-$137,700

Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Right To Work

E-Verify Participation

Apply Now

Refine Your Search

quality assurance manager jobs in wake forest, nc

Mgr., Product Complaints (Hybrid)

External Quality Operation Manager (GMP)

Quality Manager

Manager, Quality

Hub NAM Quality & Continuous Improvement Manager

Hub NAM Quality & Continuous Improvement Manager

Quality Manager

Global Quality Manager

Quality Control and Testing Manager

Traveling Quality Assurance - Quality Control Manager - MSG - Pharmaceutical

Quality Control Manager (RTP)

Senior Manager, Quality Assurance (OTC)

GMDP Quality Assurance Manager

Manager, Quality Risk

Principal Specialist, ERP S4 HANA Project Management Test Lead (Remote)

Senior Manager, Quality Operations

Validation Lead

QC Manager, Sample and Lab Equipment Management

Quality Manager (Regulated Industry)

Manager, Quality Management

I want to receive the latest job alert for quality assurance manager in wake forest, nc

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected