Biomedical Quality Engineer
Website On-Board Companies
Company : On-Board Companies
Country: United States
Location : Exton, Pennsylvania
Post: Wed, 31 May 2023 06:37:18 GMT
Expires: Wed, 28 Jun 2023 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
On-Board Services is a Biomedical Quality Engineer in Exton, PA
For immediate consideration please send your resume to
Subject Line: Position Title and State you are Located
On-Board Engineering Corp. is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Type: Full Time Contract, with plans for extension
Job Location: Exton, PA
Benefits: Health Plans (Medical, Dental, Vision) and 401k
Purpose of the job
To support the Business Unit regarding engineering activities for the ongoing and evolving stability and predictability of the supply chain. Interfacing with internal and external stake holders to appropriately qualify and maintain suppliers for all product lines. Expected tools to meet these requirements include supplier and component qualifications, data analysis, statistical process control (SPC), CAPA and KPI’s, review and trending. Supplier Quality is responsible for supplier product-related root cause analysis, process mapping and impact assessments for change control. Supplier Quality will lead in CMO/Supplier audits and associated downstream actions to meet our clients expectations. As a senior member in the supplier quality engineering team, the senior supplier quality engineer is expected to provide subject matter expertise in supplier management, understand and evolve internal systems to efficiently meet requirements, interface with vendors of all sizes, and provide leadership to the supplier quality engineering team.
Our client’s medical device expertise spans one of the broadest portfolios of medical materials, including biostable polyurethanes, ultra-high molecular weight polyethylenes, resorbable polymers, ceramics, collagens, extracellular matrices, silicone hydrogels, device coatings, and drug delivery platforms. Millions of products are produced each year for applications in orthopedics, sports medicine, ophthalmology, general surgery and cardiology.
Travel Expectations: Approximately 25%
Lead supplier management activities
Interface with internal stakeholders to lead and define deliverables for supplier qualification activities
Own the Approved Supplier List and associated supplier statuses, risk assessments, and reviews
Participate in product and process development activities to establish appropriate product requirements
Understand the manufacturing process capabilities
Serve as technical subject matter expert resource for ISO 13485 and 21 CRF 820
Complete internal audits and process assessments as required
Responsibility for supplier related nonconformances
Communicate client’s quality expectations to supply chain partners of all sizes
Review and internally document execution of deliverables from supply chain partners
Lead supplier audits/assessments
Interface with suppliers through component validation activities, design validation strategies as needed
Manage supplier corrective action process
Review supplier-initiated change requests
Lead and drive supplier improvements as necessary
Key Areas of Accountability / Responsibility under limited supervision:
Expected to serve as primary quality contact with vendors of all sizes and complexities
Own and manage the supplier qualification process and Approved Supplier List
Develop, document, and implement QA Procedures
Analyze internal systems for improvement and drive the improvement efforts
Perform external audits of CMOs/suppliers to appropriate criteria, report findings, and develop and track actions as required.
Establish and negotiate Quality Agreements with required supply chain partners
Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
Prepare, review, and approve technical reports and provide recommendations based on data rationale.
Develop, lead, and review root causes for non-conformances and deviations
Review documentation for completeness and accuracy
Complete other tasks and projects as assigned by the Supplier Quality Assurance Manager
Lead focused, multidisciplinary teams with clear objectives
Serve as leader, teacher, and mentor to other supplier quality team members
Work occasionally in a clean room setting following protective procedural requirements and comply with all safety requirements, including posted placards, SOPs and the Safety Manual.
Adhere to Quality System procedures, ISO13485, 21CFR part 820 and current regulatory standards.
SHE & Security
It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace.
Comply with all job-related safety, security, and other training requirements.
Report any SHE and Security incidents (including observed risks) to management
Show behavior in line with the SHE and Security risks and agreed controls, including being compliant to the client’s requirements, rules, and procedures.
Address any person behaving in a SHE and Security irresponsible way.
Complexity of the job
Managing interaction with multiple departments; Change Management; Site based.
Communicating technical reports to various internal and external personnel
Knowledge and educational level
Educational Level: Bachelor’s degree in Engineering or Life Sciences
Lead auditor certification
Six Sigma, ASQ QE or CQA Certification a plus.
Excellent organizational, leadership, decision-making, and analytical skills.
Excellent written and verbal communication skills, including writing, editing and proofing skills.
Well-developed inter-personal and teamwork skills to communicate and resolve product quality issues with R&D, Production, Engineering and other departments.
Demonstrated ability to multi-task resulting in positive outcome for each task assigned or self-generated.
Required level of experiences
8+ years Quality Engineering or Supplier Management within a regulated industry: Medical Device, Pharmaceutical, Biotech.
Experience with ISO 9001, or ISO 13485, or 21 CFR820 desired.
Computer literacy (Microsoft Office, Project, Document Management Systems)
Statistical techniques and software (i.e. – Minitab)
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
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