BD (Becton, Dickinson and Company) Staff Quality Engineer II in Franklin Lakes, New Jersey
Job Description SummaryThis Staff Quality Engineer II 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 standards updates, Post Market Surveillance, and Risk Management implementation.
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 become thoroughly knowledgeable with all aspects of Government Regulations and International Standards and assumes personal responsibility for the successful completion of all tasks within the realm of quality engineering responsibilities. Additionally, as new quality systems are developed, the incumbent will also be required to develop quality strategies that are applicable for the new system and may also be utilized within legacy products.
The Staff Quality Engineer II reports to WW VP Quality Management.
Serve as a multi-functional team member, establishing quality requirements and providing guidance for procedure changes.
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.
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 quality systems issues.
Develop quality strategies to improve product quality as well as provide for more efficient processing of materials/products.
Assist and/or generate field issue investigation reports and assure timely close-out of all required actions associated with the field issue investigation process during the first year of a new product post-launch.
Perform gap assessment of standards updates and implement actions to maintain compliance.
Compile and assess metrics for the sites and PAS overall to support KDGs and Management Review.
Catalog Situation Analyses, Variances and NCMRs.
Support sites during Regulatory Authority audits, including writing and implementing audit observation action items.
Write PMS plans/reports to support the EU MDR.
BS Degree in Life Sciences or Engineering or related
At least 10 years' medical device or pharmaceutical industry experience.
Proficient knowledge of Medical Device or pharmaceutical regulatory standards such as cGMP 21CFR820, ISO 13485, ISO 14971, ISO 10011, ISO 90011 and/or others relevant to Medical Devices.
Individual must understand expected results and establish efficient plans within assigned projects for self and/or team members to achieve them.
Individual must understand how process development and capability relates to product design.
Individual is expected to work in teams to obtain results, be self-motivated/directed, possess ability to organize and supervise activities with minimal supervision.
Individual is expected to independently interface with numerous functions, manufacturing plants, and supplies. The individual is expected to prioritize and balance multiple priorities and commitments independently.
Individual is expected to perform multiple tasks and possess the ability to effectively manage conflict within those tasks.
Individual is expected to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.
Excellent skills in analytical thinking and problem solving.
Excellent written and oral communication skills.
Individual is expected to be able to read and understand component and assembly drawings as well as have a rudimentary knowledge of Geometric Dimensioning and Tolerancing.
Proficiency in Microsoft Office Suite and statistical programs – i.e., MiniTab, SAS, etc.
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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.
Primary Work LocationUSA NJ - Franklin Lakes
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