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Quality Assurance Engineer II, Manufacturing

2 months ago

Southington, Ohio, United States ICU Medical Full time
FLSA Status: Exempt

Position Overview:
The Manufacturing Compliance Engineer II plays a crucial role in investigating and documenting exceptions to ensure adherence to established procedures. This position involves coordinating quality system initiatives and projects to maintain regulatory compliance. The Engineer will oversee, develop, and manage investigations, ensuring that all documentation addresses root causes, corrective actions, and product implications effectively. Additionally, the incumbent is responsible for training new Compliance Engineers to ensure they are equipped to perform their duties competently.

Key Responsibilities:

  • Conduct comprehensive investigations into process deviations, procedural exceptions, and nonconformities.
  • Provide training and mentorship for new Compliance Engineers.
  • Lead initiatives for continuous improvement in Compliance Investigations and participate in cross-functional projects within the facility.
  • Ensure thorough documentation of root causes, corrective actions, and product impact in investigations. Formulate recommendations based on procedural guidelines and critical analysis.
  • Develop, implement, and monitor the effectiveness of corrective action plans for exceptions.
  • Support activities during regulatory or third-party audits.
  • Utilize trend analysis to inform scheduling and incorporate findings into facility investigations.
  • Maintain accurate project timelines and communicate updates to management.
  • Prepare field alert reports and manage notifications to leadership.
  • Engage in committees and teams that support Good Manufacturing Practices (GMP) compliance programs.
  • Adhere to all company policies, standard operating procedures (SOPs), and ensure compliance training is current.
  • Monitor GMP and regulatory compliance activities critical during inspections, reporting violations and deficiencies to management, and recommending product release holds as necessary.
  • Perform additional related duties as assigned.
Qualifications:

  • Proficient understanding of Good Manufacturing Practices and regulatory standards.
  • Excellent communication and organizational abilities.
  • Capability to interact effectively with all management levels.
  • Strong technical writing skills for documenting investigation outcomes.
  • Problem-solving skills focusing on both personnel and processes.
  • Ability to foster a collaborative environment and build trust for addressing complex issues in investigations and corrective actions.
  • Technical expertise to identify and comprehend potential compliance issues.
Education and Experience:

  • Minimum age of 18 years.

Bachelor's Degree Required:
Engineering, Science, or Manufacturing (other relevant four-year degrees may be considered with equivalent experience)

  • At least 5 years of experience in Quality, Manufacturing, Engineering, or R&D roles, or a combination thereof.
  • Certification as a Quality Auditor (CQA) or Quality Engineer (CQE) is preferred.
  • Experience in areas such as validation principles, pharmaceutical manufacturing methods, project management, documentation systems, quality systems, or analytical/microbiological testing principles is advantageous.
  • Preferred experience in project management and quality engineering principles.
Physical Requirements and Work Environment:

  • Typical office environment with occasional access to laboratories, warehouses, manufacturing, and clean-room settings.
  • Occasional lifting of sample boxes may be required.
  • Ability to lift up to 25 lbs. unassisted.
  • Travel requirements are generally less than 5%.