Performs detailed audits of practices at company manufacturing plants and sites to ensure that policies and procedures comply with guidelines set forth in the Food and Drug Administration (FDA) manual. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions. Consults with manufacturing management to establish practices and procedures that comply with FDA regulations. May include training. May also include responsibility for pilot plant.

This position will provide internal audits as follows:

·         Scheduled audits for compliance to CORPQPM-01

·         Ad-hoc audits as needed to support process changes.

·         Ad-hoc audits to support product transfers and New Product Development.

·         Ad-hoc for cause audits (i.e to review CAPA’s, etc).

·         Drive continuous improvement activities through audit programming.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

·         Responsible for conducting, and confirming follow-up actions on Corporate/Divisional/Site Compliance Audits.

·         Plan and conduct requested audits of specific products, processes, or areas.  To include investigation, evaluation, and confirmation of follow-up. 

·         Responsible for working with QA management/teams on validations, protocol and process reviews, and implementation of requirements in compliance programs.

·         Plan and conduct scheduled audits to assess compliance with FDA, ISO, MDD, and internal requirements.  To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions. 

·         Participate in planning, coordination, and implementation of audit policies.  To include review of updated GMP/QSR regulations and current FDA and non-US requirements (ISO) and incorporation into internal programs where appropriate. 

·         Review, understand, and implement changes related to ISO/GMP changes.  Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs. 

·         Participation with Corporate and divisional QA on policy/procedure/ guideline development.  Includes generation, review, and implementation of these documents.

·         Will work with others to ensure that audit schedules are published on time and updated as appropriate

QUALIFICATION REQUIREMENTS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

MINIMUM REQUIREMENTS: To be considered for this position you must have the following qualifications:   EDUCATION, EXPERIENCE, and/or SKILLS

·         BS in Engineering or related discipline

·         5 - 8 Years experience in quality or related field

·         Strong Medical Device or Pharmaceutical background required

·         Demonstrated competence with statistical analysis, tools and software

·         Excellent communication skills

·         Knowledge QSR, ISO, & MDD laws/regulations.

·         Auditor certification for regulated environments.

PREFERRED: 

·         Engineering Degree

·         ASQ CQA Certification

·         1-3 years medical device experience

Boston Scientific is an Equal Opportunity/Affirmative Action Employer

                 Learn more about our organization at: www.bostonscientific.com/careers

                                                                                                                                                                                                      

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