Quality Supervisor, Complaints
The Quality Supervisor, Complaints, is a product quality representative that provides hands-on technical quality engineering support to lead complaint investigations for multiple manufacturing facilities and will supervise/coordinate the function activities of investigation team personnel. Provides leadership and guidance to direct reports, manufacturing sites Quality and Operation teams ensuring that investigation findings are appropriately addressed. This position will also have direct interaction with customers and Global Field sales reps. Customer conference calls and visits may be conducted to better understand product issues, identify customer concerns before issues become complaints, and speak on behalf of the Quality organization. Responsible for the accomplishment of established quality goals.
Essential Duties & Responsibilities
Be a product expert encompassing how the product was designed, how it is manufactured, associated failure modes, and how the product is used in the field.
Must have the ability to methodically process and investigate medical device customer complaints in a high paced, efficient and accurate manner.
Oversee and coordinate the receipt, documentation, and timely entry of complaints samples into the system.
Write effective investigation reports.
Assist the QA manager in ensuring that investigations are completed in a timely manner.
Provide quality support and cross functional communication of customer experiences and complaint findings with the manufacturing sites.
Liaison with Quality, Engineering, and Operations and manufacturing locations to understand ongoing CAPA investigations and product issues.
Contact US customers to address ongoing issues, proactively identify potential issues, and provide updates/summaries for ongoing quality initiatives impacting the customer
Analyze weekly and monthly trend data according to procedure to identify if there is a bias or a trend does exist.
Working effectively in a team environment with shifting priorities and time sensitive requirements.
Must be capable of carrying out basic standardized test methods and/or submit functional testing requests
A willingness and capability to work with used, and therefore contaminated Medical Devices in a controlled setting
Performs other functions as necessary or as assigned.
Work on special projects as they arise
Knowledge, Skills & Qualifications
Familiarity with cGMP, FDA, and guidelines governing the manufacture and release of medical devices.
Familiar with ASTM and ISO 9001 Standards
Demonstrated leadership skills
Strong oral and written communication skills
Ability to train/transfer knowledge to others
Use of measurement and test equipment
Must be a creative problem solver with the ability to troubleshoot a variety of issues
Proficient in Microsoft Office (Excel, Word, Database) and statistical analysis programs
Good written and verbal communications skills
Strong knowledge of Plastic Processing and disposable Medical Device manufacturing
Must have good mechanical aptitude
Demonstrate ability to safely and competently handle returned contaminated medical devices.
Education and Experience
Bachelor of Science in Engineering or equivalent technical degree
Experience working in a team environment successfully bringing medical device products through an FDA regulatory pathway and compliance with internal Quality Management System (QMS)
Experience writing requirements and specification for regulated products/applications, including design traceability and verification and validation plans.
CQE/CRE Certification desirable
Minimum 5 years of quality assurance experience in a related field
Must be 18 years of age
Must pass pre-employment drug screen and background check
Physical Requirements and Work Environment
Work is performed in a safe environment. While performing the duties of this job, the employee is regularly required to work with contaminated Medical Devices in a controlled setting: use computer to enter data; use telephone to converse with customers and employees. Must be able to occasionally move objects up to 15 lbs.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.