Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet Nuvaira, customer, and regulatory requirements. Provide focused design assurance, quality engineering support, supplier management and quality systems support.
- Develop and qualify test and inspection methods for use in validation, verification, first article, manufacturing and incoming assurance.
- Develop and/or provide support for risk assessments, FMEA (Design and Process), design v&v, process qualification, process capability, gage r&r and production control plans.
- Lead or participate in design control activities such as Design Reviews, Specification Reviews, Packaging, Standards Assessment, Labeling and Sterilization.
- Actively participate in supplier selection, audits, improvement and qualification in support of existing and new products.
- Assist suppliers in developing and executing process validations, statistical sampling plans, inspection methodology, and process control plans.
- Monitor, analyze, and drive improvement in supplier performance, including audit findings and supplier corrective action requests.
- Provide direction and lead in the implementation of acceptance activities, first article inspection, sampling plans, product/components testing, inspection and acceptance criteria
- Lead and provide technical guidance for identifying and resolving new product development quality issues.
- Act as an effective leader or team member in supporting quality disciplines, decisions, and practices
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Proactively investigate and analyze field issues and customer complaints.
- May supervise or coach technicians or other Engineering support employees. Train and/or provide work direction to technicians and engineers when required.
- Ensure Quality system complies with current standards and ensure promotion and awareness of standards throughout organization.
- Develop and conduct training for Nuvaira employees regarding quality related practices and QMS requirements.
- Monitor and audit the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement.
- Support and maintain all QMS processes and procedures, including but not limited to; Complaints Handling, Design and Development, Change Control, Risk Management, Corrective and Preventative Action, Internal Audits, Supplier Quality, Process Control, Document Control and Identification and Traceability.
- 10+ Years’ medical device experience with BS in engineering or related discipline.
- Demonstrated used of Quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, complaint investigation, process validation (IQ, OQ/PQ) and FDA, ISO/MDD standards.
- Demonstrated interpersonal skills with ability to work within a team environment
- Strong written/verbal communication skills.
- Proficiency in all Microsoft Office programs.
Preferred Qualifications: (Optional)
- Demonstrated problem solving through classical & experimental design methods
- Experience in test method development, qualification and use of test method equipment
- Experience in risk management, design assurance, design validation and design verification
- IQ, OQ/PQ, DV and Design Validation
- Experience in Acceptance Activities / First Article Inspection
- Six sigma problem solving methodologies