Senior Quality Engineer Job at ACE Partners, Salisbury, MD

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  • ACE Partners
  • Salisbury, MD

Job Description

Senior Quality Engineer – Salisbury, MA - $90k - $110k

US Citizens or GC holders only

No C2C

Are you a Senior Quality Engineer looking to lead and implement quality systems for Medical Device products in an ISO 13485 environment?

This role is critical in ensuring products meet rigorous Q uality and Regulatory standards across multiple industries, including M edical Devices . You will bring expertise in Q uality Management Systems, Regulatory compliance, and Manufacturing processes .

Key Responsibilities:

  • Oversee and approve IQ, OQ, PQ validation protocols and execution for new and existing products.
  • Manage PPAP activities and prepare submission packages.
  • Lead Quality Technician functions and provide technical expertise.
  • Participate in FMEA teams , ensuring risk mitigation in product development.
  • Develop and document control plans, inspection procedures, and test methods .
  • Conduct statistical capability studies and establish SPC control charts .
  • Perform internal process audits to ensure compliance with specifications and SOPs.
  • Monitor SPC charts to maintain process control and drive corrective actions when necessary.
  • Train production staff on quality-related procedures and best practices.
  • Support failure analysis, validation processes, and special testing as needed.
  • Maintain Standard Operating Procedures (SOPs) and ensure regulatory compliance.
  • Assist with software validation and supplier quality management .
  • Provide audit support for internal, third-party, and customer audits .
  • Lead continuous improvement initiatives and mentor quality and manufacturing engineers.

Qualifications & Experience:

  • Bachelor’s degree in engineering or a related field.
  • 3+ years of Quality Engineering experience, preferably in medical device manufacturing.

Expertise in:

  • Validation activities (IQ, OQ, PQ, MSA).
  • PPAP preparation and submission.
  • FMEA/PFMEA participation.
  • Root Cause Analysis & CAPA.
  • Internal quality auditing.
  • Supplier quality management.
  • Software validation.
  • Strong knowledge of ISO 13485, PPAP, FMEA, AIAG Control Plan Methodology, SPC, and GMP.
  • ASQ Certified Quality Engineer (preferred).
  • Proficiency in Microsoft Office and productivity tools.
  • Excellent communication, analytical, and leadership skills.
  • Occasional travel may be required.

Please Note: Candidates must be A uthorized to work in the U.S. Visa sponsorship (including H-1B) is not available for this role.

Job Tags

H1b,

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