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The Quality Engineer supports our client by working in support of production, supplier quality, and development programs.  The successful candidate is responsible for developing and maintaining quality standards, plans, and procedures to assure our products and processes meet required specifications, regulatory standards, and system requirements. The successful candidate will demonstrate a dedication to both company and departmental continuous improvement as a requirement. The QE works harmoniously and participates in cross functional team / collaboration activities to deliver highly spec compliant product results. In addition to the Required Qualifications for the role other Essential Duties and Responsibilities includes but is not limited to competency in administering QMS, Audits, Safety and other duties as assigned.

Required Qualifications:

·       Bachelor’s degree in engineering or science, or equivalent work experience.

·     A minimum of two (2) years related to manufacturing experience in a QMS environment.

·       Working knowledge ISO 13485:2016 and FDA requirements (21 CFR 820), and other equivalent applicable standards.

·       Prior experience within electronic Quality Management Systems (eQMS) such as CEBOS, Green Light Guru, Master Control, Qualio, Veeva, or similar applications and systems.

·       Highly proficient in the use of Microsoft Office including Outlook, Word, Excel, Power Point, Project, Visio, SharePoint, Teams, and Adobe Acrobat Pro.

·       Previous familiarity with Minitab or other Statistical Programs.

·       Team player with strong matrix team leadership and participatory / collaborative skills

Preferred Qualifications:

·       BS Degree in a technical field: plastics, mechanical, chemical, or biomedical engineering field and at least 5 years of relevant experience OR the equivalent combination of education.

·       5-year minimum experience from a medical device company, or similarly regulated environment.

·       Supplier Quality Engineer experience with 5 years from a medical device or Pharma company.

·       ASQ Certifications as a Quality Engineer and/or Quality Auditor.  Training methods experience is also preferred.

·       Functional Knowledge of Quality KPI & SPC.

QMS:

·       Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.

·       Investigates customer complaints, performs return sample evaluations, root cause analysis, and implements changes to the quality system where needed based upon investigations, supporting the CF coordinator by preparing and communicating the final reports to the customer.

·       Evaluates verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures.

·       Provides expertise in risk management and analysis techniques when facilitating completion of pFMEA/FMEA within a cross functional team.

·       Evaluates risk during reviews of NCs.

·       Responsible for and facilitates the development and implementation of quality engineer metrics as KPIs (Key Performance Indicators).

·       a. Implements effective measurement and analysis of the QMS, procedures and methods. Shall recommend improvements.

·       Reviews and approves controlled documents (e.g., SOPs, specifications, methods, change control, protocols, reports, investigations, deviations, CAPAs, source documentation, etc.) to ensure defined quality objectives are met.

·       Tracks reoccurring quality and compliance-related commitments and activities as related to Supplier Quality.

Audits:

·       Participates in audits, customer meetings, site visits and inspections, working closely with peers in the organization.

·       Supports the internal audits within the organization and tracks compliance of corporate QMS to applicable standards.

Safety:

·       Ensure, respect and follow workplace safety rules including, but not limited to, proper PPE, proper handling practices of chemicals per procedures, maintaining safe work practices, follow LOTO and HAZMAT polices, refer to SDS when applicable, and apply information found to the task at hand.

Physical Requirements:

·       Generally, working in an office environment and on a manufacturing floor, 50/50.

·       Travel could be required.

·       Requires data entry and regular use of computer/keyboard/mouse for extended periods of time.

·       Regularly required to stand, sit, walk, use hands to input, able to hear and talk.

 

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