Staff Quality Engineer

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Job Description Summary

Job Description

Summary - Main Purpose of the Position

The Staff Quality Engineer is accountable as Quality Assurance representative to support reagent product and process sustaining and/or new product development activities through the application of Quality engineering skills for medical devices. Emphasis will be on process, equipment, and software validations, working with teams to develop manufacturing processes and define their related equipment and software tools, determine validation strategy, and write, execute, and approve validations. Products include, but are not limited to IVD liquid and dried antibody and system calibration products. For Sustaining Product activities, this Engineer will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established regulatory and BD standards of quality. For New Product Development activities, this Engineer will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Activities include working independently or with a team to perform process validation, risk assessment and management, design control, CAPA, and supplier management. Engineer will give input to current and new Quality procedures. Successful performance requires close work with quality management, operations, R&D, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.

Primary Responsibilities and Duties

Supports quality activities for the development, implementation, and ongoing support of IVD reagent products and their related processes, equipment, and software.

Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as design and process validation, measurement systems analysis, equipment and software validation, root cause analysis, FMEAs, risk mitigation, DOE/other process improvement tools, sampling and control plans.

Applies technical principles, theories, concepts, techniques and quality sciences / tools.

Develops solutions to routine problems of medium scope.

Follows company procedures and makes procedural updates.

Demonstrates working knowledge and application of applicable regulatory, Corporate and/or Unit requirements.

Is a Core Team member, or extended team member representing Site Quality on new product development projects and a team member for sustaining engineering projects.

Acts as Quality Assurance reviewer/approver or author for documentation such as protocols and reports, deviations, and design history files

Provides audit support (preparation, closure, etc. activities)

Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, and waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement projects.

Leads and assures appropriate CAPA activities to accomplish internal/external objectives.

Process, Test Method, Equipment, and Software Validations (IQ, OQ, PQ)

Design Control (Both New Product Development and Sustaining Processes asapplicable)

Design Input

Design Output

Design Verification plans, protocols, and reports

Design Reviews

Design Validation

Design History File support

Change control

Assessment of Change Request (ACR) Responses

Risk Management

Handling of deviations and non-conformances

Supplier qualification

Post Market Surveillance Trend Review

Situation Analysis

CAPA – Root cause investigation and implementation of corrective / preventive actions

Proper Use of Statistics (Study design, Sampling Plans, and Data Analysis)

Advise on Regulations

Provide functional support to cross-functional teams

Internal and external audit support

Teach and assist associates in Quality system concepts and documentation

Other duties as assigned.Requirements:

A minimum of a bachelor’s degree is required.

A minimum of 5 years of experience in a quality related function.

A minimum of 2 years of experience in a medical device or other FDA regulated environment.Assets:

Process validation experience is a plus.

Previous work with IVD reagent products under GMP conditions is a plus.

Certified Quality Engineer (preferred)

Certified Six Sigma Green Belt (preferred)

Knowledge of applicable regulatory requirements includingISO13485, ISO14971, ISO9001, quality systems regulations (21 CFR: 820)

Knowledge of design control principles preferred.

Knowledge of process, test method, equipment, and software validation (IQ, OQ, PQ).

Training in statistics.

Ability to provide support to internal / external audits. Experience with Minitab or other statistical software, MS Excel, and MS Word required.

Primary Work LocationUSA CA - San Jose

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, or any other protected status.

Company info

Becton, Dickinson and Company (BD)
Website : http://www.bd.com/