Sr. Complaint Analyst job at LifeCell Corporation in Branchburg

LifeCell Corporation is in need of Sr. Complaint Analyst on Sun, 04 Aug 2013 10:55:18 GMT. LifeCell develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. LifeCell's leading technologies include: Strattice™, for reconstructive and general surgical procedures; and AlloDerm®, for plastic reconstructive, general surgical, burn and periodontal procedures and Cymetra®, a particle form of AlloDerm suitable for injection...

Sr. Complaint Analyst

Location: Branchburg New Jersey

Description: LifeCell Corporation is in need of Sr. Complaint Analyst right now, this job will be placed in New Jersey. For detail informations about this job opportunity kindly see the descriptions. LifeCell develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. LifeCell's leading technologies include: Strattice™, for reconstructive and! general surgical procedures; and AlloDerm®, for plastic reconstructive, general surgical, burn and periodontal procedures and Cymetra®, a particle form of AlloDerm suitable for injection.

LifeCell's patented tissue matrix was developed in 1994 as a graft for burn patients. Since then, AlloDerm's versatility has led to its use in many other reconstructive applications, allowing surgeons to restore tissue damaged through injury or disease - using the regenerative power of the patients' own tissues.

Position Summary: LifeCell is seeking a Complaint Analyst to work in a dynamic, innovative, entrepreneurial spirited environment where together we are transforming surgery If you are self-motivated, enjoy a challenge and seek satisfaction knowing your efforts are making a difference in someone's life, then this opportunity is for you.

The Complaint Analyst is a member of the Complaint Group within Quality Assurance Product Safety, and reports to! the QA Complaint Manager or Sr. Manager, QA Safety. The Compl! aint Analyst provides an accurate review of entry of complaints into the Complaint Handling Database, completion of all levels of complaint investigations, and provides complaint closure notification to LifeCell Distribution Partners. The Complaint Analyst works within the guidelines of Complaint Handling and Investigation and Adverse Event Reporting procedures to ensure compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Regulations (QSR), and other applicable regulatory guidelines as they relate to complaint handling processes. This role can provide complaint handling process training (both internal and external to the department) as directed by a QA Complaint Manager or Sr. QA Safety Manager.

Provides feedback to feeder systems to obtain corrections to incoming complaint information such as complaint description corrections, requests for additional information, non-product complaints, lot number requests! , etc.

Identifies and assesses potential reportable complaint events or adverse reactions and assigns and completes or verifies completion of complaint investigations and tasks for self and cross-functional organizations to ensure timely completion of complaint investigations.

Reviews and completes peer reviews/approvals of complaint investigations to ensure all potential reportable and adverse events are identified and investigated to the level commensurate with the event.

Performs Quality investigation for assigned complaints and driving the complaint to closure assuring that any cross-functional investigation is complete and documented within the complaint file, including examination or testing of product returns, and risk analysis.

Assesses each assigned complaint for potential product non-conformity and performs initial Quality investigation, providing sound objective evidence to assist Quality and Regulatory senior management in mak! ing field action decisions.

Prepares Adverse Event reports for! assigned complaints and submits to the appropriate Regulatory Authority within defined timeframes.

Performs data queries in Trackwise as requested.

Assists in training of new Complaint Analysts and Complaint Associates. Provides training for new employee hires during orientation. Has input to the development of complaint related training materials.

Qualifications

Position Qualifications:
A minimum of a Bachelors Degree in Life Sciences or Engineering

A minimum of 5 years quality or regulatory experience in a medical device company.

A minimum of 3 years complaint investigation and adverse event reporting

Other Required Skills:

• Proficiency with Microsoft Office business software and use of information databases.
• Proven ability to communicate effectively, orally, and in writing.
• Proven ability to work and maintain a positive environment with peers, management, all K! CI employees and customers.
• Service oriented attitude.
• Proven ability to maintain confidentiality and discretion in business relationships and exercise sound business judgement.
• Proven ability to work independently to assure completion of work.
• Proven ability to prioritize tasks and showing flexibility in day to day work in order to meet the business needs of the company.

Preferred Qualifications:

• Familiarity with data management tools.
• Experience with KCI or other medical devices.
• ASQ or RAPS member.

Our mission today is the same as it was when we began almost twenty years ago: to improve quality of life for those most in need of our help. It takes committed, caring people to achieve that vision-people with the expertise, creativity and dedication to bring new innovations to life. Maybe someone like you.
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If you were eligible to this job, please email us your res! ume, with salary requirements and a resume to LifeCell Corporation.

If you interested on this job just click on the Apply button, you will be redirected to the official website

This job starts available on: Sun, 04 Aug 2013 10:55:18 GMT

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