- About BD
- About BD
- Position Summary
- Educational Background
- Professional Experience
- Job Responsibilities
- Manages Quality Engineering staff and guides the Quality groups in BD TCI in support of product development.
- Leads development, sustenance, and continual improvement of quality systems in compliance with 21 CFR 820, EUMDR, and ISO 13485 quality systems with a specific focus on the design control requirements.
- Runs multiple projects directly while managing other quality engineering resources running separate projects.
- Ensures compliance with all local, state, federal regulations, and BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.
- Leads design control compliance within the phase gate product development process as specified for the business. Lead evolution and improvement of the product development process.
- Leads or supports cross-functional planning, coordination, and reviews. Initiates and directs QA/ QS programs for effective introduction of new products and processes to fulfill the strategic plan.
- Leads Risk Management activities for products under design authority.
- Supports quality initiatives for Site issues. Work closely with Design Owner and Manufacturing sites globally to resolve customer complaint issues by identifying root causes and developing corrective actions.
- Act as a role model/Change ambassador to establish Inspire Quality initiatives through close collaboration with many partners to influence and lead the Quality strategy
- Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans (CAPA)
- Knowledge and Skills
- Bachelor's degree in mechanical engineering or related discipline.
- Advanced knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, ISO 14971, EUMDR etc.), and quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards.
- Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements.
- Advanced leadership, motivational, and team building skills, with the ability to lead organizational change.
- Advanced interpersonal skills with the ability to manage, motivate, and influence both up and down the organization.
- Understanding of clinical setting and ability to understand customers' quality and regulatory needs.
- Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast paced environment.
- Minimum 5 years of experience in supervising technical/ quality professionals.
- Minimum 10 years relevant experience in design quality, quality record documentation, quality system requirements, GMP compliance, quality auditing,
- Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to interface with regulatory bodies to present technical information
- Successful track record of delivering quality products to market, preferably in the instrumentation and/or medical device industry.
- Experience in project planning, management, and leadership.
- Experience in a Phase-Gate development process.
- Experience of working with multi-disciplinary functional teams. Ability to serve in leadership roles on projects or assignments.
- Experience of running multiple projects directly while managing other quality assurance resources running separate projects.
- Advanced understanding of applied statistics, statistical sampling plans, and statistical process control.
- Experience of leading internal and external compliance audits.
- Practical and demonstrated experience of Quality or Reliability engineering/ QA/QS, risk analysis, product development, verification/validation testing lead in post launch quality reviews
- Global perspective and ability to integrate people and technologies from many sources.
- Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)
- Master's degree in business or related engineering discipline.
- Certified Quality Engineer, Certified Quality Manager, Certified Quality Auditor, and/or Six Sigma Green/Black Belt.
- Product design experience in the medical device industry.
- Experience in the design and development of quality products in accordance with ISO 13485 guidelines.
- Knowledge of engineering performance enhancement tools and continuous improvement in the areas of Design for Six Sigma (such as Voice of the Customer, Statistics, Design of Experiments, and Problem Solving).
-
Procedural Specialist
2 days ago
Becton, Dickinson & Company Fort Lauderdale, United StatesThe Procedural Specialist promotes BD products to customers and potential customers through clinical support and education within a defined geographic area and as directed by the Regional Manager. Job Description. We are the makers of possible BD is Specialist, Regional Manager, ...
-
Assistant Doctor in Visceral Surgery
2 weeks ago
Velocity Enterprises Lauderdale Lakes, United StatesOur client, an academic teaching hospital, is currently seeking a RESIDENT PHYSICIAN IN VISCERAL SURGERY (M/F/D) in the greater Rotenburg area. THE OFFER: * Wide range of services including minimally invasive surgical procedures * Treatment of appendicitis, gallbladder diseases, ...
-
Customer Service Representative
2 weeks ago
Capital Bank MD Fort Lauderdale, United States Full timePosition Purpose · Responsible for performing tasks directly related to servicing deposit accounts which include but are not limited to processing financial transactions, opening new accounts, processing changes to existing accounts, and conducting research to resolve problem si ...
-
Broward Health Fort Lauderdale, United StatesBroward Health Corporate Spectrum · Shift: Shift 1 · FTE: · Sourcing Specialist responsibilities include searching social networks and portfolio sites to identify potential candidates, sending recruiting emails and organizing an effective employee referral system. Responsible fo ...
-
Closing Specialist
1 week ago
Builders Capital Fort Lauderdale, United StatesBuilders Capital is looking for a seasoned Closing Specialist to join our team As a Closing specialist, you play a pivotal role in the final stages of the loan process, ensuring accuracy and compliance with regulatory guidelines. Your responsibilities include reviewing loan docum ...
-
YD Broward
1 week ago
YMCA of South Florida Fort Lauderdale, United StatesPosition Summary: · Responsible for maintaining the security and safety of actively participating students and staff during the program operation, assisting with student transitions and coordinating the dismissal and transportation for the students transition home. · Essential ...
-
Automotive Mechanical Systems
3 weeks ago
Bosch Group Fort Lauderdale, United States Full timeJob Description · The BMW Roadside Assistance (RSA) Automotive Diagnostic Agent will be responsible for providing technical product support to clients and customers of BMW. The Automotive Diagnostic Agent will use advanced troubleshooting and problem solving skills along with BMW ...
-
Information Technology Support Specialist
3 weeks ago
Medicus IT Fort Lauderdale, United StatesPresenting the Level Two role at Medicus IT, where we're taking IT support to the next level. As a Level Two IT Support Specialist, you'll spearhead the implementation of customer-facing cloud environments, on-premise infrastructure, and telephony systems, all while delivering wo ...
-
FIU SAR Control Investigator Sr.
2 days ago
Synovus Financial Fort Lauderdale, United States Full timeJob Description · Job Summary · The AML/BSA Investigator Senior is responsible for conducting high risk and complex case investigations including but not limited to, Grand Jury Subpoenas, 314(a) matches, Law Enforcement Requests, OFAC matches to ensure efficient identification ...
-
Senior Trust Advisor
1 week ago
Truist Fort Lauderdale, United States Full timeESSENTIAL DUTIES AND RESPONSIBILITIES · Following is a summary of the essential functions for this job. Other duties may be performed, both major and minor, which are not mentioned below. Specific activities may change from time to time.1. Engage with the Wealth Advisor and Inves ...
-
customer service specialist
2 weeks ago
State of Florida Fort Lauderdale, United StatesRequisition No: · Agency: Commerce · Working Title: CUSTOMER SERVICE SPECIALIST · Pay Plan: Career Service · Position Number: · Salary: $34,000.00 · Posting Closing Date: 06/30/2024 · Total Compensation Estimator Tool · Job Title: CSL - CAREER SERVICE SPECIALIST · Requisitio ...
-
National Practice Associate
5 days ago
HNTB Fort Lauderdale, United States Full timeWhat We're Looking For · At HNTB, you can create a career that is meaningful to you while building communities that matter to all of us. For more than a century, we have been delivering solutions for some of the largest, most complex infrastructure projects across the country. W ...
-
supervisor, social work services
3 weeks ago
Broward County Public Schools Fort Lauderdale, United StatesPOSITION GOAL · To develop a comprehensive delivery model of school social work services to support the academic success, educational advocacy, and social emotional well-being of students. To provide leadership, direction, and supervision to District staff in adhering to social ...
-
50197 Hub International South Florida LLC Fort Lauderdale, United States Full timeABOUT HUB INTERNATIONAL: · HUB International Limited ("HUB") is the 5th largest global insurance and employee benefits broker, providing a broad array of property, casualty, risk management, life and health, employee benefits, investment and wealth management products and servic ...
-
Pricing Specialist FT
3 weeks ago
Southeastern Grocers Fort Lauderdale, United States Hourly SpecialistOverview · Southeastern Grocers is committed to a culture of belonging and fostering an inclusive environment where we celebrate differences. As a , we empower everyone to be their full, authentic selves. Read our . · Pricing Specialist · Job Purpose · Manages the pricing integ ...
-
Collections Specialist- PIP SUIT Required
3 weeks ago
Path Medical Plantation, United StatesPath Medical is seeking a Full-time Collections Specialist · Essential Functions and Responsibilities · Assist the Collections Specialist with following up with insurance companies regarding status of payments and comply with any pending items/documents as requested. · Communicat ...
-
CVS Technologist
3 weeks ago
Broward Health Fort Lauderdale, United StatesBroward Health Imperial Point · FTE: · Summary: · Assists the Cardiologist in the performance of diagnostic and interventional procedures in the cardiovascular lab such as angioplasty with stenting and related procedures. Monitors radiation safety for physicians, patients, and s ...
-
Accounts Payable Specialist
5 days ago
PrideStaff Fort Lauderdale, United StatesAre you an experienced Accounts Payable Specialist looking to grow with a company that has a culture focused on what YOU value most? We have a job for you · The Accounts Payable Specialist supports the Accounting department by performing full cycle · accounts payable functions ...
-
Broward Health Fort Lauderdale, United StatesBroward Health Imperial Point · Shift: Shift 1 · FTE: · Summary: · The Customer Service Specialist works to identify and implement patient experience improvement activities and to ensure an excellent experience of care for patients and families in all care settings. This is acco ...
-
Peer Support Specialist
2 days ago
Broward Health Fort Lauderdale, United StatesBroward Health Medical Center · Shift: Shift 1 · FTE: · Summary: · Provides peer support for behavioral health or substance abuse programs. Provides a variety of services to healthcare professionals and clients and assists in the attainment of short-term and long-term goals. Inc ...
Procedural Specialist - Fort Lauderdale, United States - BD (Becton, Dickinson and Company)
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Job Description Summary
Manages all Quality Engineering activities associated with the product development and product support processes in BD TCI, in relation to the multiple product platforms within the MDS Utah portion of BD.
Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs.
Lead evolution and improvement of the product development process, policies and procedures which will enable design teams to respond rapidly to customer needs.
Runs multiple projects directly while managing other quality engineering resources running separate projects. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Maintains and expands QA/ QS and supervisory knowledge in areas applicable to Quality Engineering.Job Description
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 develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers.
BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
"BD, a 125-year-old global medical device company has started its Enterprise Center in Bangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be an integral part of the global network for BDX. It will have presence of R&D, Quality, Regulatory, IT and other functions. The center boasts of some of the brightest minds who work in a unique environment that fosters and supports ingenuity. BD TCI is dedicated to serving BD's customers and patients thereby contributing its bit towards "advancing the world of health".
Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs.
Lead evolution and improvement of the product development process, policies and procedures which will enable design teams to respond rapidly to customer needs.
Runs multiple projects directly while managing other quality engineering resources running separate projects. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Maintains and expands QA/ QS and supervisory knowledge in areas applicable to Quality Engineering.IND Bengaluru - Technology Campus
Additional Locations
Work Shift