Actalent

Job Title: Quality Engineer

Job Description

This Quality Engineer role supports core quality system processes to ensure compliance with applicable medical device regulations by providing operations support, tracking quality metrics, facilitating training programs, reviewing quality system records, and analyzing quality data. The position focuses on maintaining and improving the quality management system, supporting audits and regulatory activities, and collaborating with cross-functional teams to drive effective corrective and preventive actions.

Responsibilities

• Support CAPA, internal audit, document control, complaint investigation, and other quality system processes to ensure conformance with applicable regulations, standards, and corporate policies.
• Update and maintain quality management system standard operating procedures, work instructions, and forms based on interpretation of applicable quality standards, internal gap assessments, and audit findings to ensure ongoing regulatory compliance and audit readiness.
• Apply basic project management skills to complete projects on time in support of plant goals.
• Assist in updating supplier quality files and performance scorecards with accurate, current documentation of supplier performance in alignment with requirements.
• Support in-depth audits of quality system elements against internal and external requirements, including regulatory requirements, industry standards, regulatory guidance documents, corporate policies, standard operating procedures, and local procedures, documents, and records.
• Provide support for regulatory compliance processes such as product field action assessments and execution.
• Collaborate with other departments and cross-functional teams on daily tasks and projects, including CAPA records, complaint investigations, and internal audit reports and responses.
• Initiate and manage CAPA records and facilitate CAPA board meetings to ensure on-time completion and appropriate escalation when needed.
• Work cross-functionally to support investigation teams and root cause analyses and develop well-documented corrective and preventive action plans for identified issues.
• Compile, review, analyze, and distribute monthly metric reports for CAPA, internal audits, complaint investigations, and other quality system processes to identify trends and potential process improvements.
• Ensure effective communication of audit activities, status, and metrics to leadership throughout the organization.
• Support preparation for and hosting of external audits by regulatory agencies and notified bodies.

Essential Skills

• Bachelor’s degree in a science or engineering field.
• 0–3 years of experience in the medical device or pharmaceutical industry preferred.
• Experience or familiarity with quality engineering and quality systems in a regulated environment.
• Knowledge of CAPA processes, internal auditing, document control, and complaint investigation.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Basic analytical, troubleshooting, and problem-solving skills.
• Good verbal and written communication skills.
• Ability to interpret and apply quality standards, regulatory requirements, and corporate policies.
• Ability to manage multiple tasks and projects while meeting deadlines.

Additional Skills & Qualifications

• Experience in supplier quality management, including maintaining supplier files and performance scorecards.
• Background in medical device quality engineering or related regulated industries.
• ASQ Certified Quality Auditor, Certified Biomedical Auditor, or Lead Auditor certification preferred.
• Knowledge of quality system requirements such as 21 CFR Part 820, ISO-based quality standards, and medical device directives preferred.
• Experience compiling and analyzing quality metrics and preparing reports for leadership.
• Experience supporting product field actions and external audits by regulatory agencies or notified bodies.
• Exposure to cross-functional collaboration with operations, engineering, and quality teams.

Work Environment

The role operates within a regulated medical device or pharmaceutical manufacturing and quality environment that emphasizes adherence to formal quality management systems and documented procedures. The Quality Engineer works closely with cross-functional teams, including operations, engineering, and quality, and regularly interacts with internal auditors, external auditors, and leadership. The position involves extensive use of computer-based tools such as Microsoft Word, Excel, and PowerPoint for documentation, data analysis, and reporting. Work typically follows standard business hours, with additional time as needed to support audits, investigations, and key project deadlines. The environment values continuous improvement, regulatory compliance, and audit readiness, encouraging proactive identification of trends and process enhancements. Attire is generally professional and appropriate for an office-based role within a manufacturing and quality-focused facility.

Job Type & Location

This is a Contract position based out of Warrendale, PA.

Pay and Benefits

The pay range for this position is $45.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available 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 fully onsite position in Warrendale,PA.

Application Deadline

This position is anticipated to close on Jun 26, 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 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 process due to a disability, please email actalentaccommodation@actalentservices.com 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 applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.