Validation Specialist

<b>Applied Medical</b>, a progressive medical device developer and manufacturer, invites exceptional individuals to pursue careers in our innovative organization.  If you would like to be a part of one of the fastest growing and most innovative companies in the medical device industry, then Applied Medical is the place for you.  Applied?s team members enjoy an environment that allows opportunity for growth and choice in individual career paths as team members develop their skills, training and business knowledge.  Our common goal of improving healthcare through meeting the needs of clinicians and patients is achieved through the dynamics of our team and its universal dedication to improved patient outcome. 

 

 Job Description:Validation Specialist

 

Primary responsibilities include conducting and supporting process and product validation including MRP/ERP and software systems verification activities.  Background must include process validation and verification activities with risk analysis techniques including FMEA, problem-solving techniques, knowledge of QSR, ISO 13485, EN and MDD requirements as well as experience in medical device or medical products manufacturing.

 

As Validation Specialist you will be responsible for the following activities:

 Establishing, implementing and maintaining software development and validation processesDefining software and process validation requirementsCoordinating software and process verification and validation activitiesProviding support to project teams in defining & reviewing product and software requirementsProviding training to personnel engaging in validation activities

Implementing, supporting, and sustaining elements of the Company?s regulatory and quality system through procedure generation, training, auditing, and technical support

Collaborating with engineering and manufacturing for validation studies and capability studies

 

Job Requirements:

This position requires the following skills and attributes:

 Medical Device background3-5 years experienceBS or industry experience equivalence

 

The following skills are preferred:

 Knowledge of EN and MDD requirements Medical Device manufacturing background

 Company Benefits

 

Applied Medical offers an excellent and competitive compensation and benefits package.  Applied Medical is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, or national origin.

 Job Application

 If you are interested in joining Applied Medical and meet the job requirements above, please forward your resume to the email address or fax number below. In order to be considered for this position, please include your salary history. For more information on Applied Medical, please visit our website at www.appliedmedical.com.

 

Contact Information:

ValidationCareer@appliedmed.com

949-713-8205 fax

 

Validation, software, process, medical device, regulatory