Senior Product Quality Engineer
ResponsibilitiesLocation Shelton, ConnecticutUS Job ID JR-023112
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
Our dedicated team of about 14,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
If you are seeking a meaningful, impactful, and stimulating career, look no further.
Provide quality support for productLifecyle management. Responsible fordevelopment activities of products following designtransferrequirements and internal procedures.Provides general engineering services and support for product manufacturingandquality control.ThePQEis provided limited direction from the Manager to maintain the complaint and investigation processes andis capable of performingall activitiesand takes aleadership role with projects and product support.
Essential Dutiesand Responsibilities
Compiles and analyzes quality system metrics (e.g. management review, compliance metrics, post market quality assurance, etc.) in order to ensure key process indicators are identified, measured and action driven. Identifiesunacceptable trends and drives suitable corrective action
Facilitate and actively contribute to the risk management activities Management Plans,pFMEA’s, Risk Control, etc. for new and released products.
Supports nonconformance investigation, disposition and release activity as applicable
Createsappropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
Assists with thereview of complaints
Assists with thedepartment metrics and works with others to ensure department goals are achieved.
Remediation of product documentation for changes in product compliance for new or updatedstandards
Identify, investigateand implement corrective and preventive actions(CAPAs)
Participate/Lead projects related toDesignTransfers
Reviewtechnical product documentation includingdevicemasterrecords (DMRs),drawings, bills of materials, test protocols and reports,manufacturing work instructions, engineering change orders (ECO), etc.
Work with manufacturing engineer/process engineer to ensure process controls are in place
Review and/or approve reports for: test method validations,design transfer, pilot production, and processvalidations (IQ, OQ, PQ).
Write, review and / or approved quality plans to support product activities both internal and external.
Assist in external & internal audits.
Participate in project teams and company initiatives to assure compliance with Quality System requirements whileachieving company objectives.
Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC,DOE)
Bachelor’s degree in a STEM major.
5 years of quality manufacturing and ISO 9001 experience.
- Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificates from American Society for Quality(ASQ) are a plus
- Knowledge of ISO 13485, IVDR/IVDD andFDA and cGMP regulations and documentation practicesdesired
- Knowledge of Risk Management and applicable standards
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Sit; use hands to finger, handle or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/pushing/pulling and carrying products weighing up to 45 pounds
PotentialExposure to moving mechanical parts, vibration and/or moderate noise levels.
PotentialExposure to hazardous chemicals or other materials.
Personal Protective Equipment (PPE)compliantwith site specific policies/procedures must be worn in designated areas
PotentialExposure to blood.
Other (please specify):
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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