QUALIFICATIONS

· 5 -6 years of direct experience in medical device quality roles, including inspection and acceptance activities. 2-3 years relevant supervisory experience required
· High school diploma. Training in regulatory or complaint management functions or equivalent experience required
· Experience working in ISO 13485 certified environment required. Internal audit and ISO implementation experience strongly preferred
· External audit expérience a plus
· Direct experience working with QMS programs (example QT9) and corporate ERP systems (example NetSuite) at a user level required. Implementation experience a plus
· Fully competent with MS Office applications, especially Excel – where intermediate level skills are expected
· Understanding of safety requirements for lifting and equipment maintenance
· Able to work in a team environment and take direction

1) Responsible for all aspects of incoming product inspection, including testing, release, and issue resolution
a) Personally and with occasional support from staff conducts sampling and inspection according to established procedures and processes, documents same
b) Addresses non-conformities in conjunction with Quality Engineer and Management to assure timely, compliant, customer / business focused decision making
c) Maintains accurate and up-to-date metrics for use in detailed quality reporting and reviews. Generates scheduled and ad-hoc reports
2) Personally and with occasional support from staff assures outgoing shipment integrity through verification, correction of issues and ongoing improvements where necessary
a) Conducts inspection activities in accordance with approved procedures and agreed upon sampling plans
b) Documents and analyzes inspection result trends, assists in follow up and correction of root causes for repeat or critical issues
3) Through staff, manages customer returned product from receipt to subsequent complaint/return investigations including:
a) Returned product testing and complaint handling activities as outlined in the applicable procedures
b) Follow up on priority / returns
c) Managing disposition of returned product in conjunction with support areas using appropriate documentation
d) Timely, accurate, and compliant testing and analysis of returned product in accordance with internal policies and procedures
e) Tracking and reporting on return trends with regular and ad-hoc reports as necessary
f) Collaborating with Customer Care and Quality Engineering on specific issues and/or opportunities for improvement
4) Maintains regular communications with other departments such as warehouse process areas, customer care, and accounting
5) Follows all applicable policies and safety precautions at all times. Rapidly addresses potential issues, escalating as required to assure safety, quality, and compliance.
6) Responsible for the secure and accurate maintenance of the complaint database, including “Aged” or open items
7) Performs other duties as assigned, including assisting in general warehouse activities.