Current Opportunities

QUALITY ENGINEER

Job Title: Quality Engineer
Reports To: Clinical & Quality Engineering Director
Department: Quality
FLSA Status: Exempt

Primary Purpose: Plans and directs activities concerned with development, application, and maintenance of quality processes, materials, and products. Additionally, responsible for investigation manufacturing and customer nonconformance’s, determining root causes and corrective actions, reviewing and approving protocols and final reports and developing product specifications and sampling plans.

Primary Responsibilities:

  • Develops and initiates standards and methods for inspection, testing, and evaluation.
  • Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
  • Develops product specifications and sampling plans.
  • Establishes program to evaluate precision and accuracy or production equipment and testing, measurement, and analytical equipment and facilities.
  • Develops and implements methods and procedures for disposition and discrepant material and devises methods to assess cost and responsibility.
  • Direct workers engaged in measuring and testing products and tabulating data concerning materials, product, or process quality and reliability.
  • Reviews and approves validation protocols and final reports for equipment, product, and processes.
  • Resolution and continuous improvement for root causes analysis, including NCR and Compliance.
  • Investigates manufacturing and customer non-conformances (complaints) through root cause analysis.
  • Develops and implements corrective action necessary to resolve NCR/CAPA issues.
  • Conducts effectivity checks for all root cause analysis, CAPAs and document findings.
  • Formulates responses to customer complaints.
  • Facilitates improvement projects and teams.
  • Interacts with customers and suppliers routinely to ensure that product quality is constantly maintained. Addresses all product quality issues for current products. Oversees and maintains all quality functions related to packaging and manufacturing.
  • Participates in FDA inspections, ISO audits, and customer audits of the plant quality system.
  • Performs supplier and internal audits.

Education:

Required

  • Minimum if BS in Engineering, Science or related technical field.

Preferred

  • Advanced degree.

Skills and Experience:

Required

  • Minimum of 1-3 years Quality Engineering related experience and/or training is required.
  • Knowledge of QSR, ISO 13485, CFR 820 and EN regulations.
  • Knowledge of process improvement, SPC and other statistical process methods.
  • Knowledge of process and product validations.

Preferred

  • Experience in medical devices desired.
  • Experience in product packaging desired.
  • Experience in molding.

Core Competencies:

  • Time Management: Performs assigned tasks/projects in time allotted; plans accordingly to meet productivity goals; prioritizes tasks/projects appropriately.
  • Quality of Work: Performs assigned tasks with accuracy; takes price in work; follows all quality programs, processes, and procedures.
  • Job knowledge: Has a clear understanding of job duties and responsibilities; can demonstrate knowledge and understanding of job duties and responsibilities; demonstrates necessary technical skills throughout work.
  • Problem Solving: Proactively identifies problems; works methodically to identify root causes and come up with possible solutions; resolves problems considering all factors including efficiency, costs, benefits, and risks.
  • Initiative: Has a drive within self to do a better job; seeks opportunities to improve and learn more; takes on additional responsibilities; drives projects forward.
  • Communication: Provides accurate and clear information in a timely manner; listens; uses appropriate words and tone verbally in writing; presents information in way that is thorough and understandable.
  • Relationships: Respects others; works to find common ground when dealing with issues; team player; effectively works with other functions.
  • Self-Development: Self-aware of personal development opportunities; creates a plan for continued development; works with manager to accomplish development activities; invests in self.
  • Safety: Follows all safety programs, processes, and procedures; identifies and reports potential hazards or violations; drives safety initiatives and policies.
  • Drive For Results: Do everything possible to meet goals or deadlines; consistently meet or exceed commitments; aggressively pursue all assignments and projects until completion, focusing your own and others’ energy on what really makes a difference; actively seeking out opportunities to improve delivery of service and new ways of working.

Please submit your resume to hr@facetmed.com.


 

VALIDATION ENGINEER

Job Title: Validation Engineer
Reports To: VP of Regulatory Affairs
Department: Quality
FLSA Status: Exempt

Primary Purpose: The Validation Engineer plans and performs activities concerned with equipment and process validation including design, review, execution and approval of Installation, Operation and Process Qualification (IQ, OQ and PQ) protocols and final reports. The Validation Engineer will assist manufacturing with equipment specification and purchase, requirements development and process acceptance criteria. The Validation Engineer will develop and implement cost reduction and continuous improvement initiatives and perform associated validations. Following validation, the Validation Engineer will assist with regulatory documentation and with defending the work to regulatory agencies.

Primary Responsibilities:

  • Perform equipment installation and operation qualifications (supporting new process changes or complex equipment implementations) through protocol generation, execution, and final report preparation.
  • Perform process validations related to process changes or complex equipment implementations through protocol generation, execution, and final report preparation.
  • Provide project validation oversight for new equipment implementations and process changes.
  • Coordinate with the equipment users to specify the requirements.
  • Coordinate with the vendors and Purchasing to ensure that all possible validation deliverables are evaluated and potentially purchased.
  • Coordinate with other departments to ensure that validation activities (from equipment qualification through process validation) are appropriately planned to coincide with the overall project implementation.
  • Define process and equipment validation policies and develop procedures to accomplish and document projects.
  • Develop and implement new process equipment validation approaches requiring integration of new technological advances.
  • Apply specialized scientific, engineering and validation knowledge in a creative way to a broad range of difficult process equipment validation problems.
  • Initiate risk analysis and gap analysis to identify, understand, challenge, and develop process requirements and controls through qualification and validation efforts.
  • Develop to level of process expert and act as technical resource to cross-departmental functions to respond to processing issues, safeguard product quality, provide technical training to operations, implement improvement initiatives, and investigate product/process-related problems in manufacturing and packaging.
  • Maintain knowledge base relative to QSR, ISO, and FDA regulations including an understanding and familiarity with regulatory requirements, guidelines, and expectations for validation.
  • Assist with preparation of regulatory filings, answering questions from regulatory agencies, and presentations of materials in regulatory inspections.
  • Participates in FDA inspections, ISO audits, and customer audits of the plant quality system as related to validation activities.
  • Other duties may be assigned.

Education:

  • Minimum of BS in Engineering, Science or related technological field is required.

Skills and Experience:

Required

  • Minimum of 3-5 years manufacturing related validation experience in the medical device industry required.
  • Extensive knowledge and experience with QSR, ISO and FDA regulations including an understanding and familiarity with regulatory requirements, guidelines and expectations for validation.
  • Experience with equipment, process and product validations. (IQ, OQ, PQ)
  • Experience with managing multiple projects while working in a team environment.
  • Experience in participating in regulatory inspections and presenting or defending validation documentation.
  • Effective communication skills (written & verbal).
  • Training or certification in Six Sigma problem solving skills.
  • Proven technical writing skills.
  • Ability to comprehend technical information related to equipment, process and regulatory expectations.
  • Proven track record in process development and improvement including identifying improvement opportunities, developing actionable plans and implementing process changes.
  • Proficiency with standard software applications including MS Word, Excel, Project and PowerPoint.
  • Demonstrated strong interpersonal communication skills (written and verbal).
  • Ability to read and interpret documents such as safety rules, operating manuals, instruction manuals, and procedure manuals.
  • Ability to write technical reports and correspondence.
  • Ability to speak effectively, present data and defend approaches before inspectors, customers, or auditors.

Preferred

  • Seven (7) years related experience.
  • ASQ CQE is preferred.

Core Competencies:

  • Time Management: Performs assigned tasks/projects in time allotted; plans accordingly to meet productivity goals; prioritizes tasks/projects appropriately.
  • Quality of Work: Performs assigned tasks with accuracy; takes price in work; follows all quality programs, processes, and procedures.
  • Job knowledge: Has a clear understanding of job duties and responsibilities; can demonstrate knowledge and understanding of job duties and responsibilities; demonstrates necessary technical skills throughout work.
  • Problem Solving: Proactively identifies problems; works methodically to identify root causes and come up with possible solutions; resolves problems considering all factors including efficiency, costs, benefits, and risks.
  • Initiative: Has a drive within self to do a better job; seeks opportunities to improve and learn more; takes on additional responsibilities; drives projects forward.
  • Communication: Provides accurate and clear information in a timely manner; listens; uses appropriate words and tone verbally in writing; presents information in way that is thorough and understandable.
  • Relationships: Respects others; works to find common ground when dealing with issues; team player; effectively works with other functions.
  • Self-Development: Self-aware of personal development opportunities; creates a plan for continued development; works with manager to accomplish development activities; invests in self.
  • Safety: Follows all safety programs, processes, and procedures; identifies and reports potential hazards or violations; drives safety initiatives and policies.
  • Drive For Results: Do everything possible to meet goals or deadlines; consistently meet or exceed commitments; aggressively pursue all assignments and projects until completion, focusing your own and others’ energy on what really makes a difference; actively seeking out opportunities to improve delivery of service and new ways of working.

Please submit your resume to hr@facetmed.com.