- Assist in management of complaint handling system including intake, evaluation, coordination of investigations, maintenance of complaint records, development and presentation of trending reports, and regulatory reporting of device incidents.
- Daily focus on improving, implementing, and maintaining quality system in manufacturing environment e.g. calibration, product inspection and controls, and final product releases.
- Assist in Material Review Board activities ensuring proper trending, closure of issues and dispositions are appropriately addressed. Drive continuous improvement initiatives based on MRB data.
- Support in the development and maintenance of various quality system documents and records, including Device Master Records, Technical Files, QA System Release Records.
- Support QA aspects of design and development of medical devices including compilation, review, and approval of device design history files, risk management reports, coordinate design verification/design validation.
- Define, develop and manage various quality projects and validation studies to ensure compliance with global regulatory requirements.
- Assist in management of supplier qualification and supplier oversight programs. Perform external (distributor & supplier) quality assessments as needed.
- Support quality system audits and inspections performed by third parties such as EU Notified Body and regulatory authorities, including FDA.
- Support ongoing compliance of internal quality system programs including: Management Review, Employee Training, Corrective and Preventive Actions, & Internal quality audits
- Support the generation and maintain documents including; engineering drawings, labeling, IFUs, etc.
- Other duties as assigned.
- High attention to detail and accuracy.
- Proficient with metrology and metrology tools and equipment.
- Must be able to work efficiently and in an organized manner.
- Proficiency in creating and manipulation of Excel spreadsheets & Word documents and statistical analysis software.
- Must have good communication skills, both oral and written.
- Working knowledge/experience with lean manufacturing principles.
- ASQ Certified Quality Engineer (CQE) or other Quality Certifications Desirable.
- Minimum of 3 years’ experience in direct engineering support of quality management systems for medical device and manufacturing of sterile devices, (US & EU) class I, II devices.
- Working knowledge of FDA Quality System Regulation (21 CFR 820), EU Medical Devices Regulation (2017/745) & ISO 13485, ISO 14971, ISO 11135.
- Certified Quality Engineer (CQE) is a plus.
- Bachelor’s degree in an engineering discipline (Mechanical Engineering is preferred).
- Experience in process engineering/validation/test method development.
- Excellent organizational and record keeping skills.
- Ability to clearly communicate information/ideas/recommendations (verbally and in writing) with technical, administrative and management personnel.
- Internal and external quality auditing experience is desirable.
- Proficiency in information technology applications such as MS Word, Excel, PowerPoint.
- Proficiency in AutoCAD system a plus.
- Must pass a drug test and criminal background check prior to starting position.
- Day shift
- $50k/year - pay is based on experience
- This is a full-time, contract to direct position for the right candidate.