• Spectranetics
  • $81,640.00 -118,940.00/year*
  • Reedsville , PA
  • Engineering
  • Full-Time

Job Description

In this role, you have the opportunity to

Oversee the Quality Assurance in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses. The processes include the introduction/validation of new/changed manufacturing processes and their associated quality systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of quality systems.

You are responsible for
  • Ensures that appropriate quality plans are made and a suitable quality system is in place, for both NPI s as well as for ongoing manufacturing that include all stages of the manufacture of the product/system and supports Quality System design,
  • Validate risk analyses and risk mitigation plans and activities, control plans, and Quality Systems.
  • Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.)
  • Review calibration plans and records, environmental controls, and training plans and records.
  • Organize IQA audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls.
  • Approve which processes need validation/re-validation after.
  • To succeed in this role, you should have the following skills and experience
  • 5+ years as an Engineer in the related field or a combination of equivalent education and relevant experience.
  • BS in Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline, preferred.
  • Solid experience in Risk Management for medical devices ISO 14971desired
  • Regulated industry preferred
  • Statistical analysis (Minitab)
  • Proficient in the use of various measuring tools and troubleshooting equipment
  • Why should you join Philips?

    Working at Philips is more than a job. It s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

    To find out more about what it s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

    Associated topics: bioengineering, biological engineer, biology, biomaterials, biomechanics, biophysics, biosynthetic, msat, nutrition, therapeutic

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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