Overview
Quality Engineer Jobs in Kennesaw, GA at Yamaha Motor
We are seeking a dynamic Quality Assurance Manager to join our team and play a key role in developing and leading our Quality department. As part of Spectrum’s operations, you will oversee critical Quality Assurance functions, ensuring compliance with regulatory agencies such as the FDA, EPA, DEA, and more. You will collaborate with cross-functional teams and help build a strong Quality team that drives operational excellence.
Key Responsibilities
Lead the site’s Quality Assurance operations, fostering team development and operational efficiency.
Partner with cross-functional teams, including Operations and Quality Control, providing advisory support to management and team members.
Ensure compliance with cGMPs, ISO 9001 standards, and other applicable regulations.
Serve as the subject matter expert on FDA regulations and requirements, acting as the liaison for regulatory agencies.
Manage readiness and execution for audits and inspections conducted by customers, suppliers, or regulatory agencies.
Oversee the investigation and resolution of Out of Specification (OOS) reports, product/process deviations, and customer complaints.
Participate in qualifying suppliers/vendors and support Supply Chain Management initiatives.
Negotiate and maintain Quality Agreements with vendors and partners.
Develop and deliver GMP, ISO, and GDP training programs.
Oversee and maintain the ISO 9001 certification process.
Author, review, and update Standard Operating Procedures.
Drive problem-solving initiatives to resolve quality issues while adhering to project timelines.
Collect and analyze quality data, determining corrective actions to promote safety, quality, and efficiency.
Identify and implement process improvement opportunities in quality, cost, and performance.
Qualifications
Education and Experience:
Bachelor’s degree from a four-year college or university (Chemistry or other natural science background strongly preferred).
Minimum 5 years of experience in GMP environments, including hosting FDA/DEA/regulatory inspections and managing customer/supplier audits.
Proven experience managing teams and building high-performing, dynamic groups.
Proficient in handling OOS investigations, complaints, CAPAs, SCARs, and deviations.
Skilled in Change Control, Process Improvement, and Project Management.
Communication/Language Skills:
Excellent ability to read, analyze, and interpret regulatory regulations and legal documents.
Strong communication skills to respond effectively to inquiries from customers, regulatory agencies, or team members.
Confident in delivering training and presenting information to internal teams.
Preferred Certifications:
LEAN Six Sigma Certification
ISO 9001:2015 Lead Auditor Accreditation
GMP Auditor Certification
Why Join Us?
At Spectrum, we are committed to fostering a collaborative and innovative environment where you can thrive professionally. Join our mission to uphold the highest standards in pharmaceutical quality while making a meaningful impact in a critical industry.
Job Type: Full-time
Pay: From $150,000.00 per year
Benefits:
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Professional development assistance
Referral program
Tuition reimbursement
Vision insurance
Schedule:
Monday to Friday
Work Location: In person
Title: Quality Engineer
Company: Yamaha Motor
Location: Kennesaw, GA
