Provides Quality Engineering leadership and support to ensure product quality, safety, and compliance with regulatory requirements. Decisions and recommendations made by this position directly impact the quality of marketed products for domestic and international sales.
All successful candidates will work within 21CFR820, and EN ISO13485 (including applicable regional and sub-ISO standards). Additional regulations and standards may apply.
DUTIES AND RESPONSIBILITIES:
- Maintains compliance with standards and regulations (QSR, ISO 13485, ISO 14971) and drives improvements in Quality System elements.
- Executes elements of the quality system, which may include:
- Complaint process including customer interface, investigation, MDR reporting determination, record keeping and follow-up.
- Technical review of drawings, inspection plans and procedures, Change Notice documentation.
- Reporting statistical information and trend analysis on Quality Data
- Leads quality/process improvement initiatives and participates in internal auditing.
- Works with established written procedures. Participates in writing, changing, and training on procedures.
- Performs supplier audits and works with suppliers to assure quality of incoming materials
- Serves on product development teams and performs and/or advises on key design control activities for new or changed product, including
- risk management through the product life cycle,
- statistical and technical suitability of verification/validation protocols and acceptance criteria.
- requirements traceability through verification and validation.
- Performs failure investigations of products, processes and systems. Implements corrective and preventive action projects as assigned by management.
- Up to 25% Travel.
- Other duties as assigned.QUALIFICATIONS:
- Bachelor’s degree in Engineering or related technical field
- Four years medical device experience or an engineering role in a similar regulated environment.
- ASQ Certified Quality Engineer preferred. ASQ Certified Quality/Biomedical Auditor desired.
- Six Sigma certification desired.
- Strong communication skills with the ability to effectively present information and respond to questions from managers, coworkers, and customers.
- Strong technical writing, troubleshooting and problem-solving skills.
- Ability to work effectively and professionally in collaborative team settings.
- Proficient with standard business software including Microsoft Word, Excel, Access, and PowerPoint.
- Ability to read and understand engineering drawings in English.
- Proficient in statistical data analysis and presentation
- Experience in regulated systems including 21CFR820, ISO13485, etc. is required.
- Self-directed and proactive individual with a healthy sense of urgency and drive for results.
The employee is regularly required to sit, stand, walk, and reach with hands and arms. Must be able to perform in a normal office environment requiring sitting at a desk and using a computer. Specific vision abilities required by this job include close vision and color vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.