Quality Assurance Engineer
Bonfils Blood Center - Denver, CO

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Position Summary:

Responsible for the effective implementation of Bonfils’ quality assurance processes related to collection, processing, testing, storage and distribution of blood and blood components. This includes equipment/ systems specification development, validation of equipment/systems, supplier quality management, process development, technical support related to quality problems, corrective action and continuous improvement change management, process control, statistical techniques, and non-conforming material and product disposition.

Consistently demonstrates integration of Bonfils quality policy by modeling behavior that supports achieving our mission and vision, business needs, strategic goals, scorecard initiatives, values, quality objectives, ethical, customer care, and confidentiality standards at all times.

Routinely performs duties in compliance with all applicable regulatory and accrediting agencies, including but not limited to Occupational Safety and Health Administration (OSHA) regulations, the current Good Manufacturing Practices (cGMP), Affirmative Action, Equal Employment Opportunity and Fair Labor Standards Act.

Position Responsibilities:

1. Must be action-oriented and able to set priorities within scope of responsibility.

1.1. Implementation of projects includes initial evaluation and complete follow through of the project.

1.2. Consistently generates new ideas and process improvements.

1.3. Able to act decisive and willing to introduce needed changes.

1.4. Projects will require excellent time management and fully engaged in the work activities.

2. Defines and develops specifications and requirements related to collection, processing, testing, storage and distribution of blood and blood components.

2.1. Product/Material specifications and requirements

2.2. Equipment specifications and requirements

2.3. Calibration and maintenance requirements for equipment.

2.4. Software specifications and requirements

2.5. Facility and systems design, layout, workflow, environmental and utility specifications and requirements.

3. Ensures effective performance of the validation system, as assigned.

3.1. Performs validations (IQ, OQ, IQ/OQ, PQ, PPQ, PV) as required.

3.2. Perform validation according to the Validation Master Plan and/or associated validation operating procedures.

3.3. Monitors the timeliness of revalidation activities and reports to management on the effectiveness of the overall validation program.

3.4. Serves as liaison to outside regulatory and certifying agencies for validation inquiries.

4. Provide Supplier Quality Management (SQM) support as assigned.

4.1. Determines categorization of suppliers.

4.2. Analyzes and evaluates supplier self assessments.

4.3. Analyzes and evaluates supplier’s and service provider’s performance.

4.4. Assists with supplier assessments and on-site audits.

4.5. Assists in the maintenance of the Approved Supplier Lists (ASL)

4.6. Analyzes and evaluates supplier changes to equipment, materials and software against requirements.

4.7. Supports incoming materials inspection process.

5. Lead and/or facilitate continuous/process improvement.

5.1. Implements change management in an effective and efficient manner.

5.2. Assists in the development of planned and systematic process improvements.

5.3. Evaluates and provides suggestions to improve system efficiency and effectiveness.

5.4. Recommends change and process improvements.

5.5. Utilizes DMAIC/LSS Principles for process improvements.

6. Provides technical support related to quality problems with equipment, material, software or processes.

6.1. Develops, analyzes, and implements technical solutions to quality problems.

6.2. Evaluates the efficacy of the solution to the original problem.

7. Provides engineering support for audits and CACI (equivalent to CAPA) projects.

7.1. Assists internal auditors in identifying findings and observations.

7.2. Provides corrective action and continuous improvement recommendations as needed.

7.3. Monitors CACI progress in association with team members.

7.4. Closes CACI when actions are completed.

8. Measures processes with appropriate statistical techniques and applies results to process control management.

8.1. Identifies appropriate statistical techniques for process.

8.2. Develops and monitors quality indicators.

8.3. Analyzes and presents results related to quality indicators for process control.

8.4. Modifies processes as necessary based upon process control data to improve product quality and process efficiency.

9. Identifies and monitors non-conforming material and product.

9.1. Follows quality assurance processes for identification of non-conforming materials and products.

9.2. Determines dispositions of non-conforming materials and products.

9.3. Measures and trends material and product non-conformities.

10. Support training and continuing education. 10.1. Assist in establishing, planning, and presentation of training programs and continuing education programs in areas of expertise.

10.2. Participate in educational programs which have special emphasis in technical quality assurance and compliance with regulations and standards.

Minimum Education Required:

Bachelor’s degree from an accredited college or university in Chemical, Mechanical, Electrical, Biomedical, and/or Industrial Engineering.

Preferred Experience:

5-10 years in validation of Equipment/Systems

5-10 years experience in quality engineering and process development

5-10 years experience in an FDA regulated environment such as Medical Device, Pharmaceutical, or Biologics.

2-5 years experience in Continuous/Process Improvement, DMAIC/LSS, etc.

Knowledge, Skills and Abilities:

Knowledge of the following quality systems;
  • Process / Equipment validation
  • Corrective Action and Continuous Improvement (CACI) also known as CAPA.
  • Non-conforming material and product management
  • Process/Product development
  • Statistical techniques via understanding of Statistical Process Control (SPC)
Strong technical / engineering skills.

Strong written communication skills including writing, editing, and proof reading

Strong interpersonal skills

Computer skills

Excellent oral communication skills

Ability to handle multiple projects

Ability to manage technical people and information

Ability to work independently with little or no direction

This is a full time, fully benefitted position reporting daily Monday through Friday during regular business hours to our headquarters, 717 Yosemite Street, Denver CO 80230. The annual salary is $57,062 to $70,179 depending on experience.

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing. We participate in the SSA/DHS E-Verify program. To read employee rights and responsibilities under the family and medical leave act, go to www.dol.gov/esa/whd/regs/compliance/posters/fmlaen.pdf

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