Onsite- Sr Quality Engineer (Endourology)
Becton Dickinson
Summary
This position performs various quality engineering functions and owns Quality Assurance/Document Control/Design Control within the scope of their product line. This includes supporting Design Control projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D/Product Development departments. Additionally, the Senior Quality Engineer functions as a subject-matter resource for interfacing with cross functional partners in Engineering, Operations, and outside suppliers.
Job description
Job Summary
This position performs various quality engineering functions and owns Quality Assurance/Document Control/Design Control within the scope of their product line. This includes supporting Design Control projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D/Product Development departments. Additionally, the Senior Quality Engineer functions as a subject-matter resource for interfacing with cross functional partners in Engineering, Operations, and outside suppliers.
Essential Duties and Responsibilities
- Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
- Provides Quality Assurance leadership for Project Teams or Quality Department.
- Builds, reviews and approves Quality System Documents (CAPA, Audits)
- Crafts, reviews and approves Product Documents, such as Design History Files
- Creates, reviews, and approves Protocols, Process and Product Validations, Stability Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA.
- Protocols, Software Validation documents
- Mentors staff
- Provides supervision to technicians and engineers
- Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans.
- Performs Internal or Supplier Quality System Audits.
- Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
- Performs Complaint review and investigation as the need arises.
- Tracks and trends Quality Indicators.
- Collaborate with manufacturing facility or other Division Facilities.
- Serves as Independent QA Reviewer and Chairperson for Design Reviews.
Qualifications
- Strong interpersonal skills required in the areas of verbal and written communications.
- Good listening and assessment skills
- Good questioning and problem-solving skills
- Must be a self-starter.
- Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
- Plans effectively and team oriented.
Key Skills and Experience
- Ability to work independently
- Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA
- Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability
- Demonstrated history of successfully interpreting regulations, and procedures
- Demonstrated skill in statistical analysis and applied statistical methodologies
- Knowledge and understanding of IEC 60601 standards
Basic Requirements
- BS/MS Engineering (BME or EE or ME)
- 5 years of experience in FDA regulated environment, with 3 years of product design experience
- 2 years of Quality Engineering experience in a regulated environment
- ASQ Certification preferred
Requirements
- BS/MS Engineering (BME or EE or ME)
- 5 years of experience in FDA regulated environment
- 3 years of product design experience
- 2 years of Quality Engineering experience in a regulated environment
- Regulatory knowledge and experience including FDA, MDSAP, PMDA, CFDA
- Demonstrated experience working with international suppliers/manufacturers
- Demonstrated history of successfully interpreting regulations and procedures
- Demonstrated skill in statistical analysis and applied statistical methodologies
- Knowledge and understanding of IEC 60601 standards
- Strong interpersonal skills in verbal and written communications
- Good listening and assessment skills
- Good questioning and problem-solving skills
- Must be a self-starter
- Detail oriented and ability to organize large amounts of work and data
- Plans effectively and team oriented
- Ability to work independently
- ASQ Certification preferred
Company overview
Becton, Dickinson and Company (BD) is a leading American multinational medical technology company founded in 1897 and headquartered in Franklin Lakes, New Jersey. As one of the largest global medical technology companies, BD specializes in manufacturing and selling medical devices, instrument systems, and reagents while also providing consulting and analytics services. The company operates through three main segments: BD Medical (focusing on medication delivery and management), BD Life Sciences (specializing in diagnostics and biosciences), and BD Interventional (concentrating on surgical and critical care interventions). With over 72,000 employees worldwide, BD has established a significant presence in virtually every country and serves healthcare providers, hospitals, clinics, pharmaceutical companies, and research institutions. The company is publicly traded on the New York Stock Exchange (NYSE: BDX) and is a component of the S&P 500 index. BD has a long history of innovation, including developing the first insulin injection device in 1924, the first sterile disposable medical device in 1952, and pioneering safety-engineered syringes. The company continues to advance healthcare through its commitment to improving medical discovery, diagnostics, and care delivery while addressing global health challenges.