Quality Engineer - Supplier Quality Engineer 1

Ambu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Objective

The purpose of this position is to provide the level of resource necessary to improve, maintain and monitor the supplier controls and complaint handling process for Ambu USNV, ensuring compliance with established QMS procedures.

This position will also support other areas of the QMS as necessary.

Responsibilities And Essential Functions – Engineer And Engineer II

• Maintain a robust supplier quality and complaint handling program in alignment with established procedures.
• Integrate risk management into all facets of supplier quality and complaint handling.
• Apply sound and systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Lead supplier quality audits, including developing and executing supplier audit plan.
• Become the liaison between Ambu and our suppliers.
• Interact with Sales Territories (STs) to address complaints and gather information.
• Lead/coordinate supplier quality investigations (SCARs, NCRs).
• Responsible for change management of supplier quality and complaints related documentation.
• Review new and revised material and product purchasing specifications.
• Supports new supplier qualifications or supplier re-evaluations.
• Address and investigate incoming quality inspection supplier related nonconformities (NCRs).
• Provide engineering support to the incoming inspection function.
• Lead supplier and complaints related CAPAs; Act as the CAPA handler, as assigned.
• Maintain and monitor supplier scorecards.
• Responsible for complaint investigations and records.
• Coordinate complaints samples returns and disinfection.
• Complaint awareness communications.
• Responsible for sterile product documentation review and storage (certificates of conformance).
• Develop and monitor supplier and complaints key performance indicators (KPIs) for trending.
• Provide supplier quality and complaints KPIs to Management Review and Quality Review Board (QRB).
• Participate in risk management activities.
• Support internal audit activities.
• Support external audit activities.
• Review calibration records.
• Review calibrations out of tolerance assessments (OOTAs) and support with calibration remedial actions reports (RARs), as necessary.
• Reviewer/approver of changes.
• Perform other related duties and responsibilities, as assigned.
  
  

Responsibilities And Essential Functions – Senior Engineer

• Lead and provide guidance to the rest of the organization in Supplier Controls activities.
• Lead initiatives for improvement and streamlining of supplier quality practices across the organization to effectively identify and resolve quality issues.
• Become part of the internal auditing team as a certified Lead auditor for the site.
• Support front room activities by interfacing with auditors as an SME during external audits.
• Support Good Manufacturing Practices (GMP) annual training activities.
• Support non-supplier controls related CAPAs and NCRs activities, as necessary.
• Support other business areas as a SME, as assigned.
  
  

Responsibilities And Essential Functions – Senior Engineer II

• Oversee other critical functional areas of the Quality Management System (QMS).
• Provide forecast recommendations and track budget associate with Supplier Quality related activities.
• Serve as technical specialist for the organization in the application of advanced quality concepts, principles, and methods.
• Apply knowledge and expertise acquired through progressive experience to resolve crucial quality issues and/or special situations.
• Develop and lead project initiatives geared to improve the QMS and achieve the next level of Quality excellence.
• Establish strategic goals for assigned areas of responsibility geared to achieve organizational objectives.
• Supervise and guide a limited number of personnel to achieve organizational objectives, as applicable.
  
  

Authorities (Applicable To All Positions Listed Above)

• Initiate supplier NCRs and SCARs.
• Request initiation of CAPAs to the CRB.
• Stop manufacturing due to identified supplier issues.
• Place product/components on hold.
• Approve or reject change requests.
• Suggest supplier actions based on supplier performance.
  
  

Authorities – Senior Engineer And Senior Engineer II

• Reject receipt of shipments based on identified supplier issues.
• Initiate CAPAs as result of supplier audit activities.
• Initiate supplier actions based on supplier performance.
• Request discontinuation of suppliers based on performance.
  
  

Qualifications

Level: Engineer, Engineer II

• Bachelor’s degree in Engineering or technical field equivalent experience.
• 2-5 years of experience working in quality and/or quality engineering roles. Within the medical device manufacturing industry is preferred.
• 1+ years of auditing experience.
  
  

Level: Senior Engineer

• Bachelor’s degree in Engineering or technical field equivalent experience.
• 6+ years of experience working in quality and/or quality engineering roles. Within the medical device manufacturing industry is preferred.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Engineering experience and demonstrated use of Quality tools/methodologies.
• Working technical knowledge and application of quality concepts, practices, and procedures.
  
  

Level: Senior Engineer II

• Bachelor’s degree in Engineering or technical field equivalent experience.
• 10+ years of experience working in quality and/or quality engineering roles. Within the medical device manufacturing industry is preferred.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Engineering experience and demonstrated use of Quality tools/methodologies.
• Working technical knowledge and application of quality concepts, practices, and procedures.
• Strong project management and leadership skills, including the demonstrated ability to lead departmental project teams and resolve quality-related issues in a timely and effective manner.
  
  

Required Skills

• Experience with ISO 13485 and/or 21 CFR Part 820.
• Ability to travel nationally and internationally - 15 – 25%.
• Good attention to detail and organizational skills.
• Proficient at applying analytical and problem-solving tools and methodologies.
• Ability to work, interact, and communicate effectively with others.
• Effective verbal and written communication skills.
• Great technical writing skills.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Must be able to read, write and understand English.
  
  

Preferred Skills

• Auditor or Lead Auditor certification.
• Experience with EU MDR 2017/745.
• Experience with ISO 14971.
  
  

Work Environment

This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.