Quality Engineer

SUMMARY

The Quality Engineer is responsible for offering technical and quality assurance support by ensuring the quality of process inputs, work outputs, and compliance of work practices for personnel from commercial production, validation, and plant engineering. The Quality Engineer will work directly with colleagues in the planning and execution of activities while employing working knowledge of manufacturing processes, regulations, and quality management principles. The position will be responsible for various quality systems including Audit, Investigation Systems (Quality Event and CAPA), Annual Product Review, Product Complaint, Regulatory Inspections, Technical Document Review, Change Management, and/or Supplier Quality. The Quality Engineer will collect, evaluate, and interpret performance indicator data to identify sub-standard performance, compliance gaps, and/or performance improvement opportunities. The ideal candidate for this position has a strong technical background and experience in medical device or pharmaceutical product manufacturing.

ESSENTIAL RESPONSIBILITIES

• Serve as a primary resource and technical subject matter expert in the areas of troubleshooting, problem solving, process/method improvement, and the assurance of quality and compliance of manufacturing related activities.
• Provides expertise and guidance in interpreting policies, regulatory and governmental regulations, and internal regulations to assure compliance.
• Identify trends in quality/compliance to support root cause analysis and CAPA completion.
• Identify and implement quality or compliance improvements with an in-depth analysis of situations and/or data.
• Support the implementation and enhancement of the company’s QMS.
• Author, participate in, and/or approve standard operating procedures, forms, test procedures, validation/qualification protocols and summary reports, internal audits, training, technical investigations, and other documents and activities requiring quality assurance/control involvement.
• Support cross functional teams to promote and achieve quality and regulatory objectives.
• Participate in other essential responsibilities as assigned.

ADDITIONAL RESPONSIBILITIES

• Provide direct customer communication and support to manufacturing productions.
• Supports audit and inspection preparation and may support responses to observations.

EXPECTATIONS

The Quality Engineer is viewed as a subject matter expert on operational quality, pharmaceutical manufacturing, work process design and control, and technical problem solving. As such, a Quality Engineer is highly visible and must demonstrate strong interpersonal communication techniques, confident decision making, and a high level of personal/professional integrity.

• Create a team approach to quality objectives and promote “quality as a culture” across all company departments.
• Apply an advanced knowledge of commercial pharmaceutical operations quality principles and regulatory compliance requirements.
• Operate with minimal level of direct supervision.
• Perform duties following Company quality and safety standards.
• Participate in team building, training, and department communications.
• Understand and follow all attendance related policies.
• Maintain a high level of personal and professional integrity.
• Perform additional job responsibilities as assigned.

QUALIFICATIONS

Below are the guidelines for education, knowledge, skill, and/or abilities needed to perform each essential duty satisfactorily. Reasonable accommodation will be considered for individuals who are unable to meet the required qualifications.

Required:

• Must have a BS in Scientific/Technical discipline or a minimum of 3 years of working experience in a quality engineering or related role.
• Must have a minimum of 2 year of experience in a medical device and/or pharmaceutical manufacturing industry.
• Experience in 21 CFR part 4, 210, 211, and/or 820 GMP regulations. Knowledge of standards, current industry practices, and familiarity with interpretation and application.
• Must have strong written and verbal communication skills in the English language.
• Must have strong computer skills and previous experience with MS Office products.

Preferred:

• 5 years of commercial manufacturing quality assurance experience.
• 5 years of medical device and/or pharmaceutical manufacturing experience.
• Previous experience with inspections, auditing, statistical analysis, root cause analysis tools, CAPA, nonconformance and product complaint investigations, annual product review, qualifications, risk assessment models, field actions, change control, document control, validation concepts (process, equipment, computer and cleaning), product and process lifecycle development, and training.
• Demonstrated working knowledge of quality engineering principles.
• Experience working and communicating directly with customers.