Engineer III, Supplier Quality

Enable Injections Inc.•Sharonville, OH

1d•Onsite

About The Position

Engineer III, Supplier Quality Location: Onsite Status Type: Full Time QUALIFICATIONS Required: Bachelor’s Degree in Science, Health, or Engineering A minimum of four years of experience in a supplier – interacting role within a professional environment with an established QMS A minimum of four years of experience in an FDA (or other Competent Authority) regulated environment Experience navigating Quality, Regulatory, and Industry standards in the medical device or pharmaceutical spaces Preferred: Auditor Certification (e.g. CQA, CMDA) or auditor experience Experience with standards such as ISO9001, ISO13485, ISO17025, or others Experience with DQ / IQ / OQ / PQ and overall Process Validation (PV) navigation Experience with controlled environments, such as controlled room temperature, continuous monitoring, and cleanrooms or clean spaces Skills & Competencies: Supplier Corrective Action Request / Report (SCAR) navigation Corrective Action / Preventative Action (CAPA) navigation Nonconformance or Deviation investigations, including Root Cause Analysis (RCA) Experience in Quality Audit response preparation and implementation of Action Items Experience in Change Control / Change Management navigation Experience with regulations such as 21CFR210, 21CFR211, or 21CFR820 Technical Writing ability, consistent with Enable and industry expectations Adaptable Communication ability to interact with persons intra- and inter-departmentally, suppliers, and other Enable partners Self-manage, prioritize, and ensure efficient time-management of assigned tasks Employ positive influence to lead suppliers in a parallel path with Enable objectives Demonstrate Business Acumen, including strategic planning and challenge resolution Operate with the highest integrity in representation of the Supplier Management department and Enable Physical Requirements: Work in Quality and Manufacturing departments when required Ability to remain sedentary for extended periods of time Light work that includes moving objects up to 40 pounds Position requires being physically present on the premises during regular company hours or as approved by management Ability to travel approximately 20% as needed RESPONSIBILITIES Maintain the Approved Supplier List (ASL) and support ASL activities (e.g. form review and routing) Independently and / or collaboratively with the Manager, Supplier Quality, as needed or directed, provide guidance to the Enable team on the pathway for Supplier Qualification, consistent with site procedures Navigate SCARs and / or Quality Alerts with the Enable team and suppliers to ensure robust documentation and closure Support the scheduling, performance, and / or documentation of on-site and / or remote Quality audits Support the supplier evaluation and performance documentation (e.g. Supplier Scorecards) Apply a risk-based perspective with an understanding of Critical, Major, Minor, or non-GxP classification, when assessing new or approved suppliers to Enable Create and revise procedures to support the Supplier Management department and Enable Drive or assist, as needed, with the responses and action implementation associated with CAPAs, Nonconformances, Quality Audits, Change Control / Change Management, and other QMS elements Ensure accuracy of all documentation, including traceability or linkage of supplier documentation in both physical and electronic platforms (e.g. paper and SAP) Provide routine updates to department leadership, including escalation of any supplier-related challenges (e.g. component quality concerns) Develop and nurture strong collaborative relationships with the Enable supplier network to support continuous improvement efforts Other duties as assigned

Requirements

Bachelor’s Degree in Science, Health, or Engineering
A minimum of four years of experience in a supplier – interacting role within a professional environment with an established QMS
A minimum of four years of experience in an FDA (or other Competent Authority) regulated environment
Experience navigating Quality, Regulatory, and Industry standards in the medical device or pharmaceutical spaces
Supplier Corrective Action Request / Report (SCAR) navigation
Corrective Action / Preventative Action (CAPA) navigation
Nonconformance or Deviation investigations, including Root Cause Analysis (RCA)
Experience in Quality Audit response preparation and implementation of Action Items
Experience in Change Control / Change Management navigation
Experience with regulations such as 21CFR210, 21CFR211, or 21CFR820
Technical Writing ability, consistent with Enable and industry expectations
Adaptable Communication ability to interact with persons intra- and inter-departmentally, suppliers, and other Enable partners
Self-manage, prioritize, and ensure efficient time-management of assigned tasks
Employ positive influence to lead suppliers in a parallel path with Enable objectives
Demonstrate Business Acumen, including strategic planning and challenge resolution
Operate with the highest integrity in representation of the Supplier Management department and Enable
Work in Quality and Manufacturing departments when required
Ability to remain sedentary for extended periods of time
Light work that includes moving objects up to 40 pounds
Position requires being physically present on the premises during regular company hours or as approved by management
Ability to travel approximately 20% as needed

Nice To Haves

Auditor Certification (e.g. CQA, CMDA) or auditor experience
Experience with standards such as ISO9001, ISO13485, ISO17025, or others
Experience with DQ / IQ / OQ / PQ and overall Process Validation (PV) navigation
Experience with controlled environments, such as controlled room temperature, continuous monitoring, and cleanrooms or clean spaces

Responsibilities

Maintain the Approved Supplier List (ASL) and support ASL activities (e.g. form review and routing)
Independently and / or collaboratively with the Manager, Supplier Quality, as needed or directed, provide guidance to the Enable team on the pathway for Supplier Qualification, consistent with site procedures
Navigate SCARs and / or Quality Alerts with the Enable team and suppliers to ensure robust documentation and closure
Support the scheduling, performance, and / or documentation of on-site and / or remote Quality audits
Support the supplier evaluation and performance documentation (e.g. Supplier Scorecards)
Apply a risk-based perspective with an understanding of Critical, Major, Minor, or non-GxP classification, when assessing new or approved suppliers to Enable
Create and revise procedures to support the Supplier Management department and Enable
Drive or assist, as needed, with the responses and action implementation associated with CAPAs, Nonconformances, Quality Audits, Change Control / Change Management, and other QMS elements
Ensure accuracy of all documentation, including traceability or linkage of supplier documentation in both physical and electronic platforms (e.g. paper and SAP)
Provide routine updates to department leadership, including escalation of any supplier-related challenges (e.g. component quality concerns)
Develop and nurture strong collaborative relationships with the Enable supplier network to support continuous improvement efforts
Other duties as assigned