Product Complaint Analyst II

Actalent; Deutschland; Hybrid; EUR 43.000 - 53.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) Plan

Life Insurance

Disability insurance

HSA

Transit benefits

Employee Assistance Program

PTO

Zusammenfassung

Actalent is seeking a detail-oriented Product Complaint Analyst II to support a high-priority remediation and investigation initiative within its Quality team. You will review, investigate, and document product complaints while ensuring FDA regulations and GMP standards are met.

The role requires experience in complaint handling, quality systems, and regulated environments (medical devices, IVD, pharma, biotech) with strong analytical and documentation skills.

Qualifikationen

• Bachelor's degree in Biology, Chemistry, Biotechnology, Life Sciences, Engineering, or related scientific discipline preferred.
• 2–4 years in complaint handling, quality assurance, quality systems, or regulated manufacturing environments.
• Experience conducting investigations and documenting findings in FDA-regulated industries.
• Knowledge of GMPs, quality systems, complaint management, and regulatory compliance requirements.
• Excellent written and verbal communication with strong attention to detail.
• Ability to manage high-volume workload and prioritize tasks.
• Proficiency with Microsoft Office, especially Excel and Word.

Aufgaben

• Review, evaluate, and investigate product complaints to determine reportability, impact, and actions.
• Conduct thorough investigations: data gathering, root cause analysis, documentation.
• Maintain complaint records per FDA, GMP, and quality system requirements.
• Support risk assessments and quality decisions related to complaints and product performance.
• Collaborate with QA, Regulatory Affairs, Manufacturing, Tech Support, and Operations to resolve complaints.

Kenntnisse

Attention to detail

Analytical skills

Documentation

Regulatory compliance

Quality systems

FDA regulations

Ausbildung

Bachelor's degree in Biology/ Chemistry/ Biotechnology/ Life Sciences/ Engineering

Tools

Salesforce

TrackWise

MasterControl

Jobbeschreibung

Product Complaint Analyst II

Schedule: Monday-Friday | 8:00 AM - 5:00 PM | Hybrid after training (3 days remote, 2 days onsite)

Overview

We are seeking a detail-oriented Product Complaint Analyst II to join a growing Quality team supporting a high-priority complaint remediation and investigation initiative. This role is responsible for reviewing, investigating, documenting, and closing product complaints while ensuring compliance with FDA regulations, GMP requirements, and internal quality standards.

The ideal candidate will have experience in complaint handling, quality systems, and regulated environments such as medical devices, IVD, pharmaceuticals, or biotechnology. Success in this role requires strong analytical skills, excellent documentation practices, and the ability to manage multiple investigations in a fast-paced environment.

Key Responsibilities

• Review, evaluate, and investigate product complaints to determine reportability, impact, and required actions.
• Conduct thorough complaint investigations, including data gathering, root cause analysis, and documentation of findings.
• Complete and maintain complaint records in accordance with FDA, GMP, and company quality system requirements.
• Support risk assessments and quality decision-making related to customer complaints and product performance concerns.
• Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Support, and Operations teams to drive timely complaint resolution.
• Manage multiple complaint investigations simultaneously while meeting established timelines and quality objectives.
• Ensure documentation accuracy, completeness, and compliance throughout the complaint handling process.
• Contribute to complaint backlog reduction, remediation projects, and continuous improvement initiatives.
• Support quality system activities including CAPA, adverse event evaluation, trend analysis, and corrective action implementation as needed.

Required Qualifications

• Bachelor's degree in Biology, Chemistry, Biotechnology, Life Sciences, Engineering, or a related scientific discipline preferred.
• Minimum 2-4 years of experience in complaint handling, quality assurance, quality systems, or regulated manufacturing environments.
• Experience conducting investigations and documenting findings within FDA-regulated industries.
• Working knowledge of GMPs, quality systems, complaint management processes, and regulatory compliance requirements.
• Strong written and verbal communication skills with exceptional attention to detail.
• Ability to prioritize competing responsibilities and manage a high-volume workload effectively.
• Proficiency with Microsoft Office applications, particularly Excel and Word.

Preferred Qualifications

• Experience within medical device, IVD, biotechnology, pharmaceutical, or other highly regulated industries.
• Familiarity with complaint management and quality systems software such as Salesforce, TrackWise, MasterControl, or similar platforms.
• Experience supporting complaint remediation efforts, backlog reduction initiatives, or large-scale quality projects.
• Knowledge of CAPA, adverse event reporting, risk management, and post-market surveillance processes.
• Experience participating in cross-functional investigations and root cause analysis activities.

Work Environment

• Hybrid work schedule available following completion of initial onsite training.
• Collaborative team environment partnering with Quality, Regulatory, Technical Support, and Operations functions.
• Fast-paced setting focused on complaint investigations, documentation excellence, and compliance-driven outcomes.
• Opportunity to contribute to critical quality initiatives that directly impact product performance, customer satisfaction, and regulatory compliance.

Why Join the team?

This is an excellent opportunity to join a dynamic quality organization focused on driving product excellence and operational improvement. You'll gain exposure to complex investigations, cross-functional collaboration, and quality system processes while making a meaningful impact in a regulated environment.

Job Type & Location

This is a Contract position based out of San Diego, CA.

Pay and Benefits

The pay range for this position is $36.25 - $45.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in San Diego,CA.

Application Deadline

This position is anticipated to close on Sep 8, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.