Associate Reliability Specialist

K2M, Inc. - Leesburg, VA (30+ days ago)3.8


Associate Reliability Specialist
Location: Corporate Office - Leesburg, VA
Full Time
Requisition Number: req609


Summary:
Responsible for assisting and coordinating activities involving tracking customer complaints for all of K2M’s products. This position will require a basic understanding of K2M products and their use, as well as an understanding of the medical device complaint process. May perform some or all of the below functions, depending upon their specific assigned focus.

Essential Duties and Responsibilities include the following:
• Support the Reliability Engineering team with tasks related to customer complaints and data trending processes.
• Proactively communicate with sales representatives in the field and follow-up as needed relating to customer complaints.
• Coordinate and ensure timely return of products relating to customer complaints.
• Collect data from multiple sources used for customer complaint investigations, including product documentation and trend reports.
• File and maintain an organized system for customer complaint records.
• Assist with reporting on incidents / complaints data.
• Assist with trending analyses for various product lines and providing vigilance history as required.
Knowledge, Skills, and Abilities required:
• Strong organization and time management skills.
• Strong written and communication skills
• Strong decision making skills
• Ability to interpret technical documents is a plus
• Ablility to quickly and accurately enter data, create and run reports, assign tasks, keeping records, and update databases.
• Familiarity with ISO13485 preferred.

Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed here are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:
• Bachelor’s degree in technical or science-related field or equivalent work experience within a medical device manufacturing environment with direct quality system or regulatory working knowledge. Experience interacting with customers required.
• Training in FDA and ISO Quality System regulations and standards preferred.
• Training in complaints and reporting regulations and standards preferred.

Language Ability:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures and reports, and governmental regulations. Ability to write reports and business correspondence.

Math Ability:

Ability to understand engineering test reports and trending.

Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. The position requires the ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Good analytical skills are a plus.

Computer Skills:
Proficient in Microsoft Office suite, particularly Excel and Access, JD Edwards (ERP) and Sales Force (CRM) experience preferred.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls. The employee frequently is required to stand, walk, sit, reach with hands and arms, and talk or hear. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Occasional travel may be required.

K2M is an Equal Opportunity Employer