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Job Title: Quality Assurance SpecialistJob Description

Ensure products meet the highest standards of safety, compliance, and performance, supporting both day-to-day operations and long-term improvement efforts. As a key contributor to the implementation and maintenance of both company and regulatory quality standards, you will work across the full product lifecycle, supporting quality in manufacturing operations and driving continuous improvement across the organization.

Responsibilities

+ Maintain quality documentation including SOPs, work instructions, and records.

+ Support validation and verification activities.

+ Perform quality inspections, audits, and root cause investigations.

+ Ensure compliance with FDA, ISO, and customer requirements.

+ Collaborate cross-functionally with Engineering, Production, and Supply Chain.

+ Analyze and report on quality metrics and performance indicators.

+ Lead or support nonconformance investigations and corrective actions.

+ Work directly with suppliers to ensure incoming material quality.

+ Contribute to risk assessments, process change validations, and compliance audits.

+ Help deliver quality training and support document control processes.

Essential Skills

+ 3+ years of experience in quality assurance, preferably in a medical device or regulated manufacturing environment.

+ Strong working knowledge of FDA, ISO, and related regulatory standards.

+ Experience with QMS platforms and ERP systems such as SAP, Oracle, or similar.

+ Proficiency in data analysis tools like Excel, Tableau, or Power BI.

+ Skilled in root cause analysis tools such as 5 Whys, Ishikawa/Fishbone, or FTA.

+ Comfortable interpreting technical documents and working with metrology tools.

+ Ability to assess risk, document findings, and drive corrective action.

+ Effective communicator and cross-functional collaborator.

Additional Skills & Qualifications

+ Experience working in both office and manufacturing environments.

Work Environment

This role involves a blend of desk and production floor time. You should be able to navigate a manufacturing environment safely and effectively, use a computer for extended periods, and communicate clearly both verbally and in writing.

Pay and Benefits

The pay range for this position is $52000.00 - $62400.00/yr.

Health InsuranceDental InsuranceVision InsuranceDisability Insurance (likely includes both short- and long-term)401(k) Retirement PlanVariable Compensation Plan (performance-based bonuses or incentives)

Workplace Type

This is a fully onsite position in Cranberry,PA.

Application Deadline

This position is anticipated to close on Aug 5, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.