Change Control Analyst

Integra LifeSciences • Irvine, CA • 6d ago

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

This Change Control Analyst is responsible for implementation and execution of documentation, change control, and training processes based on business, regulatory and customer requirements to ensure compliance with company and regulatory requirements.

DUTIES & RESPONSIBILITIES

Initiates and executes an effective and efficient change control process in accordance to internal procedures

Lead, facilitate, and mentor teams through all stages of the change control and training process

Leads and participates in quality system improvement initiatives

Interface between functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes

Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriateness

Liaise with Change Requester and SMEs during all stages of the Change Control process, including Training process

Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight

Monitoring completion of post release tasks to ensure completion in a timely manner

Support and lead initiatives for continuous improvement

Participate in project teams for change control

Support in training needs related to the change control process

Manages periodic review process and procedures in applicable PLM Systems.

Support in the preparation, participate, and address issues related to document and change management for internal and external (FDA, BSI, etc.) audits as needed

Investigates and resolves non-conformances, audit observations, corrective and preventive actions (CAPAs) related to Change control and training process

Assists in the creation and development of metrics to evaluate the effectiveness and efficiency of Change Control Processes

May support onboarding training for new employees; collaborate with managers to align onboarding content with role-specific needs.

Monitor training completion, generate compliance reports, and collaborate with stakeholders to ensure compliance.

Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

Required

3+ Years of related work experience, including experience in Quality Systems, Information Technology for a Medical Device or a highly regulated organization

3+ years of experience in document management or using an electronic document management system

Experience working with business applications, not limited to GxP computer applications, such as Agile, TrackWise, is preferred

Proficient in Microsoft Office Applications, Adobe Acrobat, and database application

Preferred

University/Bachelors Degree or Equivalent in Science/Engineering or Business Administration.

CQA/CQE certification from the American Society for Quality (ASQ)

Solid interpersonal skills

Solid analytical and problem-solving skills

Solid communications skills

Process and Detail oriented and focus in accuracy

Ability to work in a fast-paced environment and rapidly shifting priorities,

Ability to quickly adapt and navigate different applications and computer software

Solid presentation skills

Ability to communicate with multiple levels of management.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Similar Jobs

Account Manager III

Panasonic Avionics Corporation • Irvine, CA • 40min ago

Management & Administrative

Overview Who We Are: Ever wonder who brings the entertainment to your flights? Panasonic Avionics Corporation is #1 in the industry for delivering inflight products such as movies, games, WiFi, and now Bluetooth headphon...

40min ago

Go to Apply

Donor Recruitment Account Manager

American Red Cross • Santa Ana, CA • 41min ago

Management & Administrative

Please use Google Chrome or Mozilla Firefox when accessing Candidate Home. By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best. Are y...

41min ago

Go to Apply

Entry Level Archaeologist

AECOM • Orange, CA • 1h ago

Company Description Work with Us. Change the World. At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work he...

1h ago

Go to Apply

Entry Level Biologist

AECOM • Orange, CA • 1h ago

Hospital & Medical

1h ago

Go to Apply

Hormel Foods - Entry Level Retail Sales Rep (Multiple locations)

Hormel Foods • Irvine, CA • 1h ago

Retail & Hospitality

Job description Retail Sales Representative To save time applying, Hormel Foods does not offer sponsorship of job applicants for employment-based visas for this position at this time. " At Hormel we invite difference and...

1h ago

Go to Apply

Customer Service Representative

Robert Half • Anaheim, CA • 3h ago

Management & Administrative

Description We are looking for dedicated Customer Service Representatives to join our team in Anaheim, California. In this long-term contract role, you will play a key part in delivering amazing service by managing custo...

3h ago

Go to Apply

Customer Service Coordinator

Adecco US, Inc. • Lake Forest, CA • 3h ago

Management & Administrative

Adecco is assisting a client in Irvine find an experienced customer Service Coordinator. This is a temp to hire position. Summary: Accurately process Major Account orders and confirm delivery and installation of equipmen...

3h ago

Go to Apply

Customer Service Representative

Robert Half • Anaheim, CA • 3h ago

Management & Administrative

Description We are looking for dedicated Customer Service Representatives to join our team in Anaheim, California. In this long-term contract role, you will play a pivotal part in ensuring customer satisfaction by addres...

3h ago

Go to Apply

Warehouse Route Driver

Rexel USA • Garden Grove, CA • 3h ago

Manufacturing & Warehouse

Rexel USA is recognized as a Great Place to Work! Rexel USA is a leading distributor of electrical supplies, services, and solutions, which includes the following companies: Rexel, Gexpro, Platt & Mayer. A career wit...

3h ago

Go to Apply

US Finance Business Consulting - Manager

EY • Irvine, CA • 3h ago

Finance, Accounting & Banking

Location: Anywhere in Country At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY...

3h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.