Job Title: Quality Engineer

We are seeking a dedicated and experienced Quality Engineer to ensure compliance with quality management systems and regulatory standards within our organization. The ideal candidate will lead corrective and preventive actions, facilitate risk management activities, and support process development and validation for new product introductions.

Responsibilities

• Ensure compliance with QMS, FDA 21 CFR Part 820, and other relevant standards.
• Lead corrective and preventive actions (CAPA) to address non-conformances and ensure timely closure of quality events.
• Act as a Subject Matter Expert (SME) on internal and external audits.
• Lead and facilitate risk management activities in accordance with ISO standards.
• Lead and facilitate Supplier PPAP (Production Part Approval) for NPI in accordance with internal procedures.
• Lead and facilitate Test Method Validation (TMV) and Measurement Systems Analysis for NPI.
• Support process development and associated validation and qualification for NPI.
• Monitor and ensure compliance with cleanroom environmental control procedures, including particle count, microbial monitoring, and gowning protocols.
• Monitor and ensure compliance with cleaning system control procedures, including input controls, cytotoxicity, and allowable residue levels.
• Support the validation and qualification of equipment, processes, and products, including IQ, OQ, and PQ associated with cleanroom and cleaning systems.
• Collaborate with manufacturing and engineering teams to troubleshoot and resolve production issues while maintaining cleanroom integrity and cleaning system effectiveness.
• Support continuous improvement projects to enhance manufacturing processes, reduce defects, and improve overall product quality.
• Conduct root cause analysis to investigate quality issues and develop corrective actions to prevent recurrence.
• Prepare and review technical documentation, including protocols, validation plans, work instructions, and SOPs.
• Ensure all documentation is maintained in compliance with applicable regulations and that records are accurate and up-to-date.
• Compile and report on key quality metrics, including defect rates and audit findings.
• Provide quality training to staff on cleanroom operations, regulatory compliance, and quality standards.
• Support cross-functional teams in addressing quality concerns and implementing best practices for continuous improvement.

Essential Skills

• Bachelor's degree in Engineering or related field.
• Minimum of 5 years of experience in quality engineering or related roles within the medical device industry.
• Strong knowledge of FDA regulations (21 CFR Part 820) and other relevant quality standards.
• Experience with risk management methodologies in accordance with ISO standards.
• Proficiency in quality tools and methodologies, such as root cause analysis, CAPA, process validation, statistical analysis, and GD&T.
• Excellent communication, problem-solving, and interpersonal skills.
• Ability to work effectively in a fast-paced, team-oriented environment.
• Willingness and ability to work primarily onsite.

Additional Skills & Qualifications

• CQE (Certified Quality Engineer) a plus.
• Lean Six Sigma Belt Certification a plus.

Work Environment

This role requires working primarily onsite, Monday through Friday, between 7 AM to 6 PM with flexible start and end times to be discussed with the manager.

Pay and Benefits

The pay range for this position is $100000.00 - $110000.00/yr.

3 weeks PTO

Three Health Insurance Plans offered through Anthem (two HSA options, one PPO)
✓
Accident, Critical Illness and Hospital Indemnity plans- Same robust accident plan, through Allstate, with the same wellness discounts of up to $400/year per family in the Accident plan!
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Vision plan- remaining the same, through Guardian
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Dental plan – remaining the same, through Delta Dental

Workplace Type

This is a fully onsite position in Oil City,PA.

Application Deadline

This position is anticipated to close on Feb 7, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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.

Salary : $100,000 - $110,000