Job DescriptionESSENTIAL DUTIES AND RESPONSIBILITIES- Support the Quality Team with QMS establishment, maintenance, and continuous improvement
- Collaborate with cross-functional teams to provide quality leadership, guidance, training, and support in QMS implementation/execution.
- Support validation activities, including IQ/OQ/PQ and TMV for equipment and production line process validation
- Support software validation and computer systems validation activities as required
- Own and support CAPAs, deviation, and nonconformance investigations
- Conduct risk assessments and lead failure mode and effects analysis (FMEA) activities. Ensure risks are identified, evaluated, mitigated, and documented
- Develop documentation (i.e., quality plans, procedures) to ensure compliance with applicable regulations
- Serve as the quality representative on Design and Development projects supporting completion of DHF documentation
- May perform internal QMS/process audits and support external audits (i.e., ISO 9001, ISO 13485, FDA) to ensure compliance with quality and regulatory requirements
- Support supplier quality evaluations and monitoring (audits, SCAR, and others)
- Participate in change management activities
- Perform data analysis and KPI monitoring to identify trends and opportunities for improvement.
- All other duties as assigned.
KEY COMPETENCIESTo perform the job successfully, an individual should demonstrate the following competencies:
- Independence-Must have the ability to work independently and be able to step outside of your comfort zone for the purposes of QMS Module development and support: proactively takes on new tasks and sees them through to completion, escalates issues/roadblocks as appropriate
- Training-Must be comfortable training other employees, including leadership teams, on newly implemented QMS modules as well as other quality-related topics
- Safety-Implement safety practices into daily workload to protect self and others
• Customer Service-Responds promptly to customer needs; responds to requests for service and assistance
• Interpersonal Skills-Able to communicate within the team and cross-functionally
• Ethics-Works with integrity and ethics; upholds organizational values
• Organizational Support-Completes tasks correctly and on time
• Planning/Organizing-Prioritizes and plans work activities; uses time efficiently
• Quality-Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; monitors own work to ensure quality and compliance
• Quantity-Meets productivity standards; completes work in a timely manner
• Attendance/Punctuality-Is consistently at work and on time
• Dependability-Follows instructions, responds to management direction, takes responsibility for own actions, and completes tasks on time or notifies the appropriate person with an alternate plan
• Oral Communication-Listens and gets clarification; responds well to questions
• Teamwork-Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit
• Diversity-Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; builds a diverse workforce
EDUCATION AND QUALIFICATIONS- Bachelor's degree (engineering, science, or a related field preferred) or commensurate offsetting experience in quality engineering.
EXPERIENCE- 5+ years of hands-on experience in medical device quality engineering
- Experience with QMS development and implementation is a plus
- Experience with FDA-regulated products and ISO 13485 certified QMS
- Experience in product development, including implementing appropriate controls
- Working knowledge of statistics is required, with Six Sigma Green Belt (or higher) certification being a plus
- Working knowledge of FDA regulations (21 CFR 820) and other relevant standards is strongly preferred
- Experience in a medical device start-up environment is strongly preferred
- ASQ certification as a Quality Engineer is a plus
- Experience in performing QMS audits is preferred, with certification as a Quality Auditor being a plus
- Experience in optics/ophthalmic is a plus
- Proficiency with Minitab, MS Outlook, MS Word, and MS Excel
- Experience with ISO 14971 risk management is a plus
DEMONSTRATED ABILITIES- Attention to detail and excellent problem-solving skills
- Excellent written and verbal communication skills
- Ability to identify potential roadblocks and provide innovative solutions
- Ability to work independently and in a collaborative team environment
- Operate with a high level of integrity and professionalism
- Ability to learn new software programs as required
- Ability to travel up to 10%
- Humble, hungry, and People-smart with a willingness to learn and grow
- Find fulfillment in building and maintaining QMS's and supporting a quality culture
- Thrive in a dynamic environment with continually shifting priorities
- Ability to manage communication and training with knowledge of different training techniques
WORK ENVIRONMENTEnvironmental: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical: While performing the duties of this job, the employee must occasionally lift and/or move up to 30 pounds.
PHYSICAL DEMANDSWhile performing the duties of this job, the employee is regularly required to sit and to use hands to grasp and manipulate. The job requires working near moving mechanical parts, fumes or airborne particles, UV rays, and toxic or caustic chemicals. The work environment noise level is usually moderate.
SAFETY REQUIREMENTS- Basic understanding of the Injury and Illness Prevention Program and the Hazard Communication Program
- Closed-toe shoes with heel support may be required where needed
- While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment may require P.P.E.
- Safety glasses and long-sleeve shirts may be required where needed
