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Position Reports To: Designated Manager or Supervisor
Position Directly Supervises: No one
Job Division: RA/QA
Over-time Status: Exempt
Purpose Of Position: To ensure products are developed and manufactured according to quality procedures and meets all applicable specifications and requirements.
To fulfill this position successfully, an individual must be able to perform each essential function satisfactorily.
- Conducts engineering activities in compliance with FDA Regulations, ISO 13485, and other national and international quality and regulatory requirements and standards.
- Leads product quality assurance and quality engineering activities to drive strong engineering and technical knowledge.
- Creates quality assurance, engineering programs, and initiatives to ensure products are developed and manufactured according to applicable requirements.
- Collaborates on investigations of NCR’s and complaints as necessary; suggests corrective and preventive actions based on engineering analysis and review; suggests effective solutions to drive continuous and measurable improvements.
- Works with various departments to ensure highest quality products and processes are developed, deployed, and meet all engineering requirements; activities include but not limited to product design testing, process testing, characterization, qualification, validation, and risk analysis/FMEA.
- Collaborates to create systems for the identification, analysis, correction, and prevention of quality issues; identifies areas for improvement as needed.
- Participates in quality engineering projects from inception to deployment.
- Participates in CAPA Management and other quality engineering projects.
- Participates in trainings for quality engineering tools within the organization using ISO 14971.
- Collaborates with team members to provide technicians and R&D personnel to provide technical leadership in problem resolution, process streamlining, and continuous improvement activities.
- Analyzes data and trends; reports results to management.
- Collaborates with team members to complete failure investigations and root cause analysis.
- Collaborates in design verification testing for design control projects.
- Performs returned product analysis and failure investigation activities.
- Ensures procedures and regulations are adequately followed during NCMR process.
- Ensures calibration and preventive management systems meet compliance requirements.
- Identifies the optimization of complex manufacturing processes using engineering methods for manufacturing design and continuous process improvement.
- Identifies opportunities for re-design and/or design of more complex equipment, tools, and fixtures to improve manufacturing processes and reduce risk.
- Performs other related duties and projects as business needs require at direction of management
The preceding functions have been provided as examples of the type of work performed by employees assigned to this job classification. Management reserves the right to add, subtract, or change the job functions.
Minimum Qualifications: The requirements listed below are representative of the knowledge, skill, and ability necessary to successfully perform the essential functions of the position.
- Education and Experience:
- Bachelor’s degree in Science or related field; or equivalent combination of experience and training; advanced degree preferred
- Minimum three (3) years of experience in quality engineering and risk management.
- Demonstrated proficient English communication skills, both written and verbal.
- Demonstrated strong interpersonal skills and capability to effectively communicate with all levels of the Company.
- Demonstrated consultative and relationship management skills.
- Demonstrated active listening skills.
- Must be able to effectively present material to large and small groups.
- Ability to establish productive working relationships with individuals of all levels.
- Ability to create and compose written materials with proper English grammar and punctuation.
- Ability to communicate effectively in a multi-cultural business environment.
Knowledge, Skills, and Abilities:
- Proficient knowledge of general office procedures.
- Demonstrated knowledge of policies, procedures, and guidelines relevant to quality compliance.
- Demonstrated knowledge in Microsoft Office Suite (Excel, Word, Outlook, and PowerPoint).
- Demonstrated problem-solving, critical thinking, and investigate skills.
- Demonstrated attention to detail and accuracy.
- Ability to learn and be proficient in internal and applicable external policies, procedures, and standards.
- Ability to manage confidential information with discretion.
- Ability to interact professionally with all organizational levels.
- Ability to manage competing priorities in a fast paced environment.
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
- Ability to identify, interpret, and apply ANSI/ASQ Z1.4 and Z1.9 standards for attributes and variables sampling.
- Ability to identify and distinguish between single, double, multiple, sequential, and continuous sampling methods.
- Ability to work in a team environment.
- Demonstrated knowledge in selecting and describing appropriate uses of inspection tools.
- Ability to interpret the concepts of producer and consumer risk and related terms, includes but is not limited to operating characteristics (OC) curves, acceptable quality limit (AQL), and lot tolerance percent defective (LTPD).
- Demonstrated knowledge of quality systems.
- Ability to adhere to quality systems.
Physical Demands: The physical demands listed below are representative of those that must be met by an employee to successfully perform the essential functions of this position.
- Ability to frequently bend and/or twist at waist/knees/neck to and from seated position while working at desk/bench and reaching for equipment.
§ Ability to frequently use standard office equipment such as but not limited to computers, telephones, copiers, and scanners.
§ Ability to constantly communicate with others.
§ Ability to maintain long periods of mental alertness and attention to detail while setting priorities, meeting critical deadlines, and following up on assignments.
§ Ability to constantly perform sedentary work, spending extended periods of time at desk or workstation.
§ Ability to seldom stand and/or walk for extended periods of time.
§ Ability to seldom climb stairs at some locations.
§ Ability to seldom push and/or pull up to five (5) pounds.
§ Ability to seldom lift or carry up to five (5) pounds.
§ Ability to keyboard for extended periods of time.
§ Ability to function in an environment with frequent interruptions.
§ Ability to deliver quality results under high pressure deadlines in a fast-paced environment.
§ Ability to demonstrate normal manual dexterity and eye-hand coordination; maintain corrected hearing and vision to normal range.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position.
- Primarily an office setting environment with moderate noise levels and no direct exposure to hazardous physical substances.