Quality Manager

Bertelsmann; Memphis (TN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, vision, life

401(k) with company match up to 6%

Paid time off and holidays

Flexible spending accounts

Voluntary benefits (legal/financial, R

Employee Assistance Program

Tuition reimbursement and training

Job summary

Arvato, a leading global 3PL provider, seeks a QA Manager Healthcare to oversee pharmaceutical and medical device QA, ensuring adherence to GMP/GDP and GxP in a regulated environment. You will drive quality policy, training, and KPI reporting across departments in a fast-paced logistics setting.

The role requires 5+ years in quality in regulated contexts, ISO/FDA knowledge, and strong coordination and communication skills.

Qualifications

• Bachelor’s degree in a scientific, technical, or quality-related field; or equivalent work experience.
• 5+ years of experience in a quality role in a regulated environment (medical device, pharma, biotech, or logistics).
• Working knowledge of ISO 9001, ISO 13485, and FDA 21 CFR Part 820 requirements.
• Proficient in document control systems and training program coordination.
• Excellent attention to detail and organizational skills.
• Strong verbal and written communication abilities.
• Proficiency with Microsoft Office.
• Experience with MasterControl or similar eQMS platforms preferred.

Responsibilities

• Continuous improvement and compliance of the local quality management system (ISO 9001, ISO 13485 and other country specific requirements).
• Flexible adaptation of the Quality Management System to all requirements (e.g. requirements of authorities, customer requirements).
• Oversight of all quality technical related processes, e.g. maintenance, calibration, pest control.
• Supporting the strategic implementation of the Quality policy and Global Quality System.
• Reporting of quality KPIs and enforcement of the specified quality in cooperation with all departments involved, including Complaints / Deviations / CAPA / Change Management.
• Responsible for the execution of training, according to the respective requirements.
• Decision on the further use of products (blocking, release).
• Guarantee of the written separation of responsibility with the customer and suppliers regarding all activities.
• Close collaboration with other departments, e.g. sales and account management, as well as the global quality team.
• Participation in project and process alignments, preparation and performance of management reviews.
• Completes assigned MasterControl Action Items within required timelines to ensure timely resolution and compliance with quality system expectations.

Skills

Quality management

GxP compliance

ISO 9001 / ISO 13485

FDA 21 CFR Part 820

Document control

Training coordination

Attention to detail

Communication skills

MS Office

MasterControl / eQMS

Education

Bachelor's in science/engineering/quality

Tools

MasterControl

Job description

Arvato is an innovative and leading global 3PL service provider in supply chain management and e-commerce. With 20,000 team members at over 100 locations, we focus on the Consumer Products, Tech, Healthcare, Automotive and Publisher industries.

You will work in an environment built on collaboration, respect, commitment and curiosity, where you can grow, contribute your ideas, and make an impact. Be part of the team that delivers logistics excellence and shapes supply chains globally. Working at Arvato means: Together, we’re on it.

Job Description

The position of the QA Manager Healthcare includes all activities related to Quality Assurance of pharmaceutical products and medical devices to ensure a proper implementation of the quality policy, the quality assurance system, the compliance with GMP/GDP rules and all GxP requirements in accordance with e.g. EN ISO 9001, EN ISO 13845 and other country specific requirements. This role is also responsible for ensuring that all requirements for Quality Assurance are understood and adhered to by the respective departments.

YOUR TASKS

• Continuous improvement and compliance of the local quality management system (ISO 9001, ISO 13485 and other country specific requirements (e.g. GDP, GMP, FDA, etc.))
• Flexible adaptation of the Quality Management System to all requirements (e.g. requirements of authorities, customer requirements)
• Oversight of all quality technical related processes, e.g. maintenance, calibration, pest control
• Supporting the strategic implementation of the Quality policy and Global Quality System
• Reporting of quality KPIs and enforcement of the specified quality in cooperation with all departments involved, including Complaints / Deviations / CAPA / Change Management
• Responsible for the execution of training, according to the respective requirements Decision on the further use of products (blocking, release)
• Guarantee of the written separation of responsibility with the customer and suppliers regarding all activities
• Close collaboration with other departments, e.g. sales and account management, as well as the global quality team
• Participation in project and process alignments, preparation and performance of management reviews
• Completes assigned MasterControl Action Items within required timelines to ensure timely resolution and compliance with quality system expectations

YOUR PROFILE

• Bachelor’s degree in a scientific, technical, or quality-related field; or equivalent work experience
• 5+ years of experience in a quality role in a regulated environment (medical device, pharma, biotech, or logistics)
• Working knowledge of ISO 9001, ISO 13485, and FDA 21 CFR Part 820 requirements
• Proficient in document control systems and training program coordination
• Excellent attention to detail and organizational skills
• Strong verbal and written communication abilities
• Proficiency with Microsoft Office.
• Experience with MasterControl or similar eQMS platforms preferred

WE OFFER

• Medical, Dental, Vision, Life Insurance, and Disability Pay
• 401(k) with company matching up to 6%
• Paid Time Off, including paid holidays
• Flexible Spending Accounts
• Voluntary benefits such as legal and financial assistance, pet insurance, and more
• Employee Assistance Program
• Ongoing employee development opportunities including tuition reimbursement, scholarships, and training

Additional Information

All your information will be kept confidential according to EEO guidelines.

Disclosure requirements pertaining to the collection of your personal data:

Responsible for processing the information provided in your application is the company specified in the job advertisement, with its registered office as indicated. The company processes your data for the purpose of establishing an employment relationship on the basis of Art. 6 (1) b GDPR / Section 26 (1) sentence 1 BDSG.

The retention period for your data is determined by the statutory time limits applicable in the respective country, beginning upon completion of the recruitment process. You can find these here .

You can contact the company’s Data Protection Officer at the above-mentioned postal address.

Further information on data protection and your rights can be found here .

We strive to be an equitable and inclusive workplace for our employees and value their diverse perspectives, which contribute to the diversity of our company. Therefore, we welcome applications from people who enrich our company with their identity, background and personal experience.

Job Segment: Quality Assurance, Medical Device, Logistics, Agronomy, Pharmaceutical, Technology, Healthcare, Operations, Agriculture, Science