BD (Becton, Dickinson and Company) Senior Advanced Quality Engineer (AQE) in Warwick, Rhode Island

Job Description Summary

Job Description

Summary of Position with General Responsibilities:

To assure that new product designs and the processes for manufacturing them meet all Corporate and

Divisional requirements with respect to safety and efficacy. Be an active team member and crossfunction

collaborator on new product development and product enhancement project teams for

implantable medical devices. Be an active team member for investigating quality complaints,

examining non-conformances and executing CAPAs.

Essential job Functions:

Product Development:

· Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.

· Development of Test Protocols and Final Report to support Regulatory 510K, PMA, CE mark and

International registrations.

· Support Pre-Concept Front End Product Innovation Process activities for new technologies.

· Lead Quality Engineering Projects to improve Quality systems and Procedures.

· Development of the DFMEA, coordinating input from the other Design Sub-team members.

· Development of the Final Design Verification Protocol and the subsequent Final Design Verification

Report including an analysis of all data and a decision on design acceptability.

· Development of the Design Validation Protocol and the subsequent Design Validation Report

including an analysis of all data and a decision on design acceptability.

· Provide input into the project Design Input Summary (DIS), Product Performance Specification

(PPS), Product Development Plan (PDP), and applicable design control documents as defined per

Davol’s product development process.

· Determine the degree of Biocompatibility testing required as per ISO10993 and company procedures.

Co-ordinate the testing at an outside lab and document results.

· Develop or assist in development of inspection and test methods per product specifications.

· Develop test protocols and release a final report on Shelf Life and Stability Studies in support of

expiration dating.

· Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and

reproducibility of analytical or physical test methods used to assess the safety and efficacy of device s.

· Develop shelf life and stability test protocols and reports as required.

Released

Process Development:

· Develop and document the Control System for the manufacture of new products including Inspection

Plans for the inspection of components, sub-assemblies and final product.

· Support the development of manufacturing control plans for internal and outsourced processes.

· Support (or lead) development of the PFMEA.

· Perform and/or Support Process Development Studies to determine the acceptability

of new processes or equipment.

· Design and qualify inspection test methods and equipment.

· Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing

facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP’s, and

ISO13485:2003 requirements.

· Lead supplier part qualification activities including mold qualification and DOEs.

· Support Process Transfers to the Production facilities.

Other:

· Make dispositions of rejected nonconforming components and products; conduct

MRB action when required.

· Organize and generate detailed quality information reports to show trends and the

impact of process improvements.

· Support Process Transfers to the production facilities.

· Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality

Engineering.

· Support the development and effective implementation of Corrective and Preventive Action Plans to

resolve quality non-conformances.

· Perform DOE’s and other statistical analysis to support product and process optimization or

determine causes of process variation. Initiate corrective actions as required.

· Provide technical support to resolve quality problems in development, pilot, manufacturing or with

suppliers as warranted.

· Support goals of the Quality Assurance Department.

Key Relationships

Internal Relationships:

- Quality & Regulatory Affairs Personnel

- Production Supervisors & Managers

- Manufacturing & Ind. Engineers

- Product Managers

- Product Development Engineers

- Buyers

- Schedulers

External Relationships:

- Suppliers/Subcontractors

- Customers

- Other Bard Divisions

Scope and Impact of Position:

The scope of the work is across all phases of development activity, including vendors and

suppliers. The work has an impact on product function, product release dates, product

quality, and product costs.

Basic Qualifications:

· B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, Technical science, or

equivalent combination of Bachelors Degree and related work experience.

· A high level of competence in Quality Technology, statistical techniques, and six sigma tools

including: sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis

of variance, regression, and design of experiments.

· Strong Design Control understanding from concept to launch; especially in post-market

activities (including complaints, failure investigations, and CAPAs).

· Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001.

· With B.S., minimum of 5 years experience in Quality Engineering discipline including design

controls, product/process validation, risk management, and technical problem solving

· With M.S., minimum 4 years experience in Quality Engineering discipline including design

controls, product/process validation, risk management, and technical problem solving

· Travel flexible

· Good oral and written communication skills.

· Ability to work with and motivate people.

Primary Work LocationUSA RI - Warwick

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status