Senior Quality Assurance Engineer

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs.  With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

The Company

PerkinElmer is a global analytical services and solutions provider with offerings including the leading OneSource Field and Laboratory services business that serve the biopharma, food, environmental, safety and applied end markets to accelerate scientific outcomes. Since 1937, PerkinElmer has served as a trusted partner in laboratory analysis and management and today complements its service offerings with a broad portfolio of atomic spectroscopy, molecular spectroscopy, and chromatography instruments, consumables, and reagents. With a dedicated team of more than 5,500 team members, the Company serves customers in more than 35 countries. Additional information is available at www.perkinelmer.com

Purpose

The Senior Quality Assurance Engineer (QAE) provides guidance, expertise, and services to ensure process and product quality of instrument products. The QAE supports compliance to the ISO 9001 quality system; internal auditing; material, process, and production controls; and other aspects of quality assurance to ensure compliance to standards, regulations, and guidelines. The QAE works cross-functionally with R&D to support new product introduction; with Manufacturing to create and modify procedures to ensure requirements are met; with Procurement to ensure incoming material meets specifications and suppliers meet quality standards; and within Quality to ensure overall compliance of products and processes.

Responsibilities

• Demonstrate knowledge of and adherence to site safety requirements.
• Execute goals and strategy for corporate and site level activities based upon company’s business objectives.
• Support supplier quality management activities, including audits and supplier performance evaluations.
• Investigate customer complaints and internal non-conformances, leading root cause analysis and implementing corrective and preventive actions.
• Participate in new product development projects, providing input on design for manufacturability and quality.
• Collaborate with various teams and leadership to develop and implement quality assurance strategies, policies, and procedures.
• Conduct regular inspections and tests on products, materials, equipment and processes to ensure compliance with quality standards and regulations.
• Analyze quality data and metrics to identify trends, root causes of issues, and opportunities for improvement.
• Develop and maintain quality documentation, including standard operating procedures, work instructions, and quality records.
• Lead or participate in cross-functional teams to address quality-related issues and drive continuous improvement initiatives.
• Maintain accurate records and reports related to quality control and compliance activities.
• Perform other duties necessary for the effective operation of the QMS.

Basic Qualifications

• Bachelor’s degree in engineering or related field
• 3+ years of relevant working experience in a customer quality, process quality or engineering role, preferably in a manufacturing environment.
• Experience with root cause analysis, corrective actions, and quality improvement methodologies (e.g., Six Sigma, Lean).
• Ability to support Quality Management during audits and inspections.
• Excellent analytical and problem-solving skills, with the ability to interpret technical data and drawings.
• Knowledge of computer software like SAP, Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to prioritize and work independently and proactively is critical for success.

Preferred Characteristics

• Previous experience in an ISO 9001, 13485 or GMP compliant manufacturing environment
• Previous experience with quality management system software for quality data tracking and document change management (e.g., TrackWise, MasterControl, Agile, QCBD, etc.)
• Internal auditor certification.