Job Description
Pay Range: $44.70/hr - $49.70/hr
Requirements / Must Have
* Bachelor’s degree in Engineering or Scientific field.
* Minimum 2+ years of experience in supplier quality, manufacturing, or quality engineering functions.
* Experience in a highly regulated industry (medical device, pharma, biotech, or similar).
* Knowledge of supplier qualification and validation processes.
* Experience supporting risk management and validation activities.
* Ability to manage multiple projects and changing priorities.
* Strong communication and organizational skills.
Responsibilities
* Ensure compliance with all Federal, State, local, and company regulations, policies, and procedures.
* Work with suppliers to ensure quality system and product requirements are clearly understood and met.
* Help define supplier qualification requirements for OEM and custom materials/devices.
* Ensure validation methods for critical suppliers and incoming quality control align with device risk, internal standards, global regulations, and industry best practices.
* Support Design Development File requirements related to supplied components, subassemblies, devices, and services.
* Support supplier risk management and validation activities.
* Develop inspection methods and procedures for receiving inspection and/or supplier final release.
* Execute test method validation activities.
* Assess non-conformances and lead closure of Supplier Corrective Action Requests (SCARs).
* Support Client and CAPA processes as needed.
Preferred Qualifications
* Engineering degree.
* Experience conducting supplier/vendor audits.
* Experience with Class II and Class III medical devices.
* Knowledge of FDA and international regulatory standards for medical devices.
* Proficiency in Design Controls, risk management, and test method validation.
* Experience with root cause analysis, dFMEA, Gage R&R, and other statistical/quality tools.
* Demonstrated ability to conduct root cause investigations and corrective action assessments (NCRs/SCARs).
* Ability to read and interpret engineering drawings.
* Six Sigma XX Belt and/or LEAN Manufacturing experience.
* ASQ Certified Quality Engineer (CQE) or ASQ/BSI Certified Quality Auditor preferred.
* Strong time management and ability to work independently with minimal supervision.
Skills And Competencies
* Strong analytical and problem-solving skills.
* Effective communication and conflict resolution abilities.
* Highly organized with strong documentation skills.
* Ability to collaborate effectively with external suppliers.
* Results-driven mindset with attention to detail.
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