13 days old
2018-06-062018-07-06

Document Control Supervisor - CSF Valves & Catheters

Medtronic
Goleta, CA
  • Job Code
    41554
Company Medtronic
Job Title Document Control Supervisor - CSF Valves & Catheters
JobId 41554
Location: Goleta, CA, 93117, USA

Description
Document Control Supervisor - CSF Valves & Catheters

Location:

Goleta, California, United States

Requisition #:

180003GI

Post Date:

Mar 06, 2018

The **Document Control Supervisor** hasresponsibility and authority to supervise all activities of Document Control function. This responsibility encompasses the support, coordination and supervision of the Document Control staff. In this role, you will provide management briefings and timely reports reflecting the status of all Document Control efforts to relevant issues, including service performance levels. You will schedule and plan work for documentation control and work closely with all departments (customers) to assist them in achieving company goals. In this role, you will apply yourunderstanding of company technical documentation systems and Quality System requirements to continuously assess, evaluate and make improvements in documentation systems. Assists in the development and revision of department policies and procedures. Ensures that releases and changes are documented and approved and that records and computer data files are current.

**_Do meaningful work, make a difference, and improve lives — starting with your own._**

**A Day in the Life**

• Supervise Document Control employees to support the engineering and manufacture of medical devices to meet customer requirements in accordance with FDA QSRs, ISO 13485, MDD/AIMD, and company standards.

• Plan, establish, and revise Document Control personnel work assignments. Interviews and recommends hiring of employees. Initiates recommendations for changes in classification, salary action, promotion, demotion, transfer and termination.

• Prepare and manage thebudget in accordance with AOP and business objectives.

• Apply yourunderstanding of company technical documentation systems and Quality System requirements to continuously assess, evaluate and make improvements in documentation systems configuration. Work closely with system users and IT to optimize systems.

• Establish and maintain customer service levels to support production and new product development. Compile departmental performance measures and report these measures at Quality Review.

• Identify areas within the current system for efficiency gains and recommends solutions.

• Identify, implement, and maintain state of the art electronic document management and control systems for operation in accordance with regulations and business objectives.

• Assist project team members in developing new production procedures, processes and routers.

• Serve as an expert in MNS documentation to provide training for Production, Engineering, Technologists and other employees as necessary.

• Ensure that releases and changes are documented and approved, and that configuration records and computer data files accurately reflect the current status of device documentation.

• Ensure proper new item setup in Agile, ManMan, OMAR, Enterprise Product Registry (EPR), and SAP. Ensures change control practices are used for revisions to this data in these systems.

• Manage the Local Data Administration (LDA) for the business unit.

• Record and maintain data, set up filing and cross-reference systems. Develop and maintain revision status logs and other applicable files.

• Maintain onsite and offsite documentation storage. Ensure that all Device History Records are electronically scanned prior to being stored in an offsite location.

General Responsibilities may include:

• Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.

• Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.

• Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.

• Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

• Co-ordinate legal requests in support of government investigations or litigations.

• Ensure that quality assurance programs and policies are maintained and modified regularly.

• Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

The **Restorative Therapies Group** develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

**This team works with products related to Cerebral Spinal Fluid Valves and Catheters.**

**Come for a job. Stay for a career.**

**Required Qualifications/Must Haves:**

EDUCATION REQUIRED:

+ Bachelor degree

YEARS OF EXPERIENCE:

+ 1+ years of experience with Document Control

+ 2+ years’ experience in managing documentation systems and change control management in a manufacturing environment or QA background in medical device or pharmaceutical environment.

+ 1+ years supervisory experience

+ 1+ years of Agile experience

**Preferred Qualifications:**

• Experience in Documentation Management Systems concentrating on converting non-related systems into managed automated systems

• Demonstrated ability to supervise others, establish measurable objectives, and evaluate performance.

• Working knowledge of CIMS computer operations (ManMan)

• Working knowledge of FDA QSR, ISO 13485, MDD/AIMD requirements

• Working knowledge of Electronic Data Management Systems

• Excellent Microsoft Office skills (Word, Excel, Outlook, PowerPoint, and Visio)

• Excellent problem solving skills

• Excellent interpersonal skills

• Excellent written and verbal communication skills

• Demonstrated ability to manage multiple projects and establish priorities

**Physical job requirements:**

The physical demands described within the Responsibilities 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

•The employee is required to be independently mobile

•The employee is required to interact with a computer, and communicate with co-workers

**RTG (Restorative Therapies Group) Overview**

The **Restorative Therapies Group** develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

BRAIN THERAPIES offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improvethe precision and workflow of neuro procedures. Cerebral Spinal Fluid valves and catheters aid in the treatment of hydrocephalus.

SPINE THERAPIES shape spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.

SPECIALTY THERAPIES offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.

PAIN THERAPIES offers solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.

**ABOUT MEDTRONIC:**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

**EEO STATEMENT:**

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

**DISCLAIMER:**

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

**_Come for a job. Stay for a career._**It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Document Control Supervisor - CSF Valves & Catheters

Medtronic
Goleta, CA

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Document Control Supervisor - CSF Valves & Catheters

Medtronic
Goleta, CA

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