This position is responsible for assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry. The incumbent will cross-functionally support all quality activities and enforce regulatory requirements in support of new product development activities.
The position requires a self-motivated, self-directed individual able to handle multiple projects and tasks utilizing a high level of written and oral communication skills. The incumbent will be knowledgeable with all aspects of large capital/new product development projects and assumes personal responsibility for the successful completion of all tasks within the realm of quality engineering responsibilities. Additionally, as new products are developed, the incumbent will also be required to develop quality strategies that are applicable for the new product.
The Staff Quality Engineer II reports to the Associate Director, Quality Management.
Serve as a multi-functional team member, establishing quality requirements and providing guidance for sustaining and n product development projects.
Review process development/validation protocols for effectiveness and compliance to Corporate Guidelines.
Assess risk commensurate to product design requirements and regulatory compliance within sales regions as new products are developed.
Assist in developing methods to measure, validate and assure quality standards are achieved for applicable product lines.
Serve as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results.
Establish/maintain documentation for compliance and effectiveness.
Develop monitoring systems and action plans designed to maintain stability of the manufacturing process and to correct adverse situations.
Maintain knowledge of current technological advancements and industry standards for regulatory and compliance where deemed necessary and appropriate.
Use disciplined problem-solving processes and skills to diagnose and prevent/solve product design and manufacturing process issues.
Develop quality strategies to improve product quality as well as provide for more efficient processing of materials/products.
The successful candidate must have the following:
Bachelors Degree in Science, Engineering or a related technical field
A minimum of 8 years relevant experience with a combination of equivalent education
Requires experience in Design Control applications as it applies to New Product Development within the medical device industry
Medical device experience in a high volume manufacturing environment
Quality engineering skills in technical tools
Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements (FDA, ISO)
“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.”
Internal Number: R-380750
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.