Career Opportunities: Quality Compliance Engineer - Scholle IPN - USA

Summary:

The Quality Compliance Engineer is responsible for the identification and implementation of continuous improvement initiatives, based on Regulatory Compliance requirements and the Internal Audit Program. Responsible for the internal audit program at the facility, providing training and guidance for the site audit team.  Assists the Quality Manager with the planning of required audits (internal and external) as assigned. Train and coach local audit team members on the how to conduct audits, documentation of findings, audit team development of audit action plans.  Also responsible for evaluation of results of audit with required plan of actions to closure.  Monitors the timely completion of corrective action plans and coordinates the reporting of compliance metrics to site manufacturing facilities management.  Functions as a subject matter expert for regulatory compliance and auditing issues.

Key Duties and Responsibilities:

As an at-will employer, Scholle IPN reserves the right to add to or modify this list to the extent it deems necessary.

• Provides leadership and guidance in timely communication/escalation of site issues associated with regulatory compliance/audits findings to the Quality Manager.
• Maintains comprehensive knowledge of applicable regulatory requirements and their interpretation. Provides regulatory compliance expertise by sharing external regulatory industry trends as well recommending actions to address any potential impact to the Client site.
• Supports site management in the development audit metrics and summaries for distribution to key management. Identify and communicate systemic issues to site Management for further comprehensive action.
• Directs the internal auditing function and team members for the implementation of regulatory and quality system effectiveness audits. In coordination with the site Quality Manager will schedule and implement plans for comprehensive annual reviews of the regulatory compliance and internal audits areas taking into consideration quality metrics, results of internal audits and external inspections, industry trends and the external regulatory environment.
• Coordinates and conducts routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards and other applicable requirements.
• Provides leadership and assists as necessary in critical supplier audits.
• Provides auditor training to audit team members & supporting auditors through on-the-job training.
• Maintains a high degree of personal professional development
  Key Competencies:

• Lean/Six Sigma Fundamentals
• Process Technical Mastery
• Quality Engineering
• Statistical Process Control
• GMP’s & Food Safety
• Regulatory Compliance Supplier Assessments & Qualifications
• Communicating Effectively
• Managing Time
• Resolving Conflict & Problem Solving
  Education:

• Bachelor’s degree is required, Engineering or related discipline preferred.
  Work Experience and/or Skills:
• 3+ years of quality, compliance and Quality experience in the Medical Device Industry, Combination Products
• 2+ years managing Compliance/ Audit programs and conducting audits in the medical device or drug industry preferably in a plant function
• ISO 13485 experience is a must
• Experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices, pharmaceuticals and combination products.
• Demonstrated ability to direct and provide advice on the use of process excellence and system design methodologies and tools to investigate and determine root cause, assess compliance risk and establish comprehensive and effective actions plans.
• Effective Project Management, Communication and Organizational Skills are Essential.
• Demonstrated ability to effectively collaborate and partner with all levels of management in corporate and division level sites while maintaining an appropriate assertive style is critical.
  Certifications & Licenses:

• Certified Quality Engineer or ISO 9001, 13485 lead auditor
  Physical Requirements:
  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Must be able to move and/or lift up to 50 pounds occasionally.
• Frequently standing, walking and sitting.
• Frequently required the use of hands to feel, reach or handle machinery.
• Frequently bend, stoop and reach
• Visual Acuity (VA)
  Work Environment:
  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• Moderate working conditions
• Exposure to variable noise levels.
• Often exposed to moving mechanical parts.
  Safety and Quality Management:
  Quality and Safety is EVERYONE’S responsibility! You must report or correct any food safety or potential food safety hazard to the person who can correct it. Adherence to policies and procedures related to quality management, safety, SQF and other regulatory guidelines communicated during your new hire orientation and defined in your Scholle IPN handbook are mandatory. Quality and Safety will be managed!
  
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