BD · 2 months ago
Quality Engineer II (Instrument Plant)
Sparks, MD
Full-time
Onsite
Entry, Mid Level
$73K/yr - $121K/yr
2+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing the world of health. The Quality Engineer II is responsible for ensuring compliance with Quality Systems, supporting audits, and leading root cause investigations for moderate complexity issues in the plant/department.
Health CareMedical DeviceTechnical Support
Responsibilities
Maintain International Organization for Standardization (ISO) and regional regulatory requirements. Key elements focus on multiple aspects of quality for product design, manufacturing (assembly and test), inspections and customer complaints throughout the product life cycle
Develop Device History Files and maintain in a manner consistent with regulatory requirements
Generate process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations and solutions to emerging issues, to share with project team/operations/suppliers
Supports the coordinated integration of new products into Manufacturing / Operations
Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies
Understanding and coaching others on Quality Systems and procedures
Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools
Skilled in working in a team environment, ability to perform multiple tasks, effectively manage conflict and drive for results with minimal supervision
Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations
Computer skills in word processing, spreadsheets and a statistical package required. Must have excellent communication skills
Knowledge of manufacturing processes, use of statistical tools required, and knowledge of microbiological and chemical test methods are preferred
Experience using statistical methods is required. Familiarity with Design Control requirements and knowledge of Medical Device Validations is preferred
Qualification
Required
Bachelor's degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs. Other fields can be considered with the appropriate experience to support the role. An advanced degree can make up for experience requirement
2+ years' experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations
Experience in a medical device or pharmaceutical manufacturing facility
Ability and skill to effectively manage multiple tasks and drive execution of change management plans
SAP transaction experience
Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity
Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003
Skilled in working in a team environment, ability to perform multiple tasks, effectively manage conflict and drive for results with minimal supervision
Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations
Computer skills in word processing, spreadsheets and a statistical package required
Must have excellent communication skills
Experience using statistical methods is required
Preferred
Knowledge of microbiological and chemical test methods
Familiarity with Design Control requirements
Knowledge of Medical Device Validations
Preferable contract manufacturing familiarity
Familiarity with DHF, DMR, HA, pFMEA, dFMEA, RMP/RMR/BRA
Preferable first-hand experience with audits
Preferable familiarity with manual assembly manufacturing
Preferable familiarity/background in microbiology/molecular science
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
EIN Presswire
2026-01-09
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