SUMMARY:
This position will oversee a diverse group of functional investigations that will be performed within the scope of the Quality department.
ESSENTIAL FUNCTIONS:
Conduct investigations into Medical Device Reports (MDR’s) with products with respect to applicable Federal regulations including 21 CFR 820, 803 and in accordance with ISO 13485 and internal Standard Operating Procedures
Assume lead role in investigating potential manufacturing / process issues with a goal of identifying potential root cause and assessing potential finished device impact
Investigation, monitoring, and follow up on CAPAs for completion and effectiveness
Author and approve investigation findings
Communicate with company personnel as to status of complaint investigation, recommended course of action, and the need for additional medical and/or supplementary information relevant to complaint investigations
Communicate with Quality departments as to the status of product analysis and the need for additional information relevant to the report
Able to participate in Risk Analysis activities including FMEA and PFMEA
Attention to detail and skill at auditing to ensure accuracy
Ability to work cross-functionally with various groups that have opportunity to impact the investigation outcome (Engineering, Operations, Quality, Commercial Operations, etc.)
Work closely with Quality Audit to assess current procedures/work instructions related to Quality and address deviations/findings
Monitor complaints received and provide trending and metrics as determined necessary for inclusion in management review
Review as needed Device History Records (DHRs) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for final review and product release
Complete all required training applicable to assigned position
Additional duties as requested or required
Required Skills Required Experience
QUALIFICATIONS:
Bachelors in Engineering or science related field; Masters preferred
Experience working with heavy equipment and machinery
Five (5) years of process engineering, quality engineering, or investigatory experience in the medical device or FDA regulated field
Six Sigma Belt certification preferred
Life science field quality certification (CQE) preferred
Prior experience with root cause investigation tools and complaint file documentation
Knowledge of FDA (21CFR 803/806/820) and ISO (ISO:13485) regulations
Organized and details oriented; proven ability to meet deadlines
Strong analytical skills; verbal, and written communication skills
Ability to work individually and as part of teams
PC KNOWLEDGE TO INCLUDE MS WORD, EXCEL, POWERPOINT, ACCESS & VISIO, AND DATABASE MANAGEMENT
An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet