About Elevaris Medical Devices

Tired of working at a "good" job?

At Elevaris, our goal is not to be good, it's to be extraordinary.

Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.

Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

About the role

This position is responsible for supporting quality documentation activities. Responsibilities include filing, copying, and scanning quality documentation using an effective and efficient document control system to ensure accuracy, completeness, and immediate availability of critical records. The role also includes managing document close-out activities and maintaining organized, compliant files in accordance with quality system requirements.

What you'll do

• Review and ensure accuracy of Quality documentation
• MasterControl (eQMS) tasks; Create Courses and Exams for new documents, revise Exams as needed and assists with the review and release of Engineering Change Orders as received
• Monitor status of in-process document changes to ensure timely approvals
• DocStar proficiency to provide daily scanning and filing of Quality documentation such as daily shipping packets, Receiving Reports, Inspection Data, Sorting Records, Complaints, NCR’s, SCARs, CAPA’s, RA’s, and as necessary other related documentation
• Update, reconcile and maintain the DHR files in both QA and Operations, including closure of files
• Provide monthly Document Control Metrics report
• Provide monthly On-Time Training Metrics
• Process daily Training reports to ensure employee-assigned training tasks are completed in a timely manner
• Prepares Quality & Operations documents for off-site storage, including scheduling pickup via the Iron Mountain website
• Supports Quality Audits and QA projects as necessary
• Supports QC on an as-needed basis in the generation of Certificates of Compliance for product shipments to customer
• Prepare and/or generate QA Inspection documentation
• Suggest & support continuous improvement
• Cross-functional project collaboration, as needed
• Upholds and role-models company Values of Integrity, Invested, Inclusion and Ingenuity
• Other duties as assigned by management

Qualifications

Minimum Requirements

• High School Diploma or equivalent
• 1-2 years relevant experience in a document control role

Preferred Skillset

• Associate or bachelor’s degree preferred
• Experience working in a medical device company
• Excellent organizational, verbal, written communication and problem-solving skills
• Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive and collaborative manner
• Ability to work in a fast-paced environment and to meet tight deadlines
• Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
• Ability to multi-task with strong attention to detail
• Proficient in MS Office Suite
• Knowledge of ERP/MRP systems, helpful

PHYSICAL DEMANDS & ADA STATEMENT:

The physical demands described within the Essential Functions section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation 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 be independently mobile. The employee is also required to interact with a computer and communicate with peers, co-workers and external partners. Contact your manager or HR to understand the Work Conditions and Physical requirements that may be specific to your role.

An Equal Opportunity Employer/Contractor: Elevaris believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.