Sr. Quality Engineer - Medical Device Manufacturing - CQE - CQA

Sr. Quality Engineer with Medical Device Manufacturing experience

  • Saint Louis, MO
  • $100,000 - $120,000
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A bit about us:

We have an outstanding career opportunity for a Sr. Quality Engineer with medical device or related experience to join a growing, global Medical Device Manufacturer located in the beautiful St. Louis, MO. area.

We are searching for an experienced Quality Engineer who will ensure products and services are developed, manufactured, tested and delivered according to the established procedures.

The position provides quality engineering support in the areas of deviation management, change control, internal auditing, quality trends, quality costs, training, corrective and preventive actions, process control, customer complaints, calibrations, documentation control to ensure compliance with the FDA and other regulatory requirements.

Why join us?

We offer an exciting and dynamic work environment along with an area competitive salary and an above average benefits package.

Job Details

Responsibilities:

  • Participate in regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of manufacturing quality.
  • Resolve, and trend department deviations, ensuring compliance of all records to quality procedures.
  • Provide periodic trend reporting as required (QSMR, weekly and quarterly trending, monthly site metrics).
  • Participate in the site Internal audit and compliance review programs.
  • Act as principal Quality contact for department risk management activities.
  • Participate and provide guidance for Supplier change checklist process, as required.
  • Act as a quality contact for evaluation of incoming QC and in-process materials.
  • Ensure the disposition of non-conforming materials meet all necessary site and regulatory requirements.
  • Provide quality support and approval signatures for Validations, Verification's, Qualifications, and Technical Reports, as required.
  • Provide input and approval in QC inspection methods as needed.
  • Act as Change Review Board chair person and Quality reviewer/approval for change management activities.
  • Review Bill of Material (BOMs), Assembly Procedures, Drawings, and Component Specification for accuracy.
  • Monitor the manufacturing of assigned products and ensuring compliance while providing deviation/waiver guidance.
  • Ensure complete and correct Device History Records are maintained.
  • Participate in the development and execution of training programs (GMP, risk analysis, statistics, etc.) as needed.
  • Support continuous improvement and global projects as needed.

Requirements:

  • Bachelors degree in a Scientific field.
  • Minimum of 5 years related experience with competence in the selection and use of Quality Engineering Tools and Techniques.
  • Medical device or related manufacturing experience a must.
  • Ability to effectively communicate written and verbally.
  • Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
  • Must have a expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
  • Certification in one of the following is highly desired: CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.
Easy Apply Now
Easy Apply Now
Job Details
Location
Saint Louis, MO
Job Type
Permanent
Compensation
$100,000 - $120,000