Senior Supplier Quality Engineer Job Description
Senior supplier quality engineer
provides ESC RDE leadership for ISO 9001 / 13485 / GMP compliance, including: training associates, leading external and internal audits as required, addressing corrective actions in response to such audits.
Senior Supplier Quality Engineer Duties & Responsibilities
To write an effective senior supplier quality engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included senior supplier quality engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies
Understand and apply the manufacturing quality toolset including PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard gauging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC
Recognize nonconforming conditions and lead cross-functional teams through robust, systematic root cause analysis
Ensure delivery of effective corrective actions
Prepare and present supplier performance data in forums containing team members from multiple organization levels
Identify emerging nonconformance trends
Participate in new product development team activities in the development and qualification of suppliers
Execute functions needed to support change control activities and document management requirements
Collaborate with business partners and peers to define validation and change control activity requirements for individual projects
Ensure validation activities are conducted in a compliant but cost effective manner
Senior Supplier Quality Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Supplier Quality Engineer
List any licenses or certifications required by the position: ASQ, CQE, CQA, CSQP, ISO, AS9100, OEM, QMS, VDA, PED
Education for Senior Supplier Quality Engineer
Typically a job would require a certain level of education.
Employers hiring for the senior supplier quality engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Technical, Science, Education, Mechanical Engineering, Manufacturing, Medical, Life Science, Industrial, Chemistry
Skills for Senior Supplier Quality Engineer
Desired skills for senior supplier quality engineer include:
FMEA
SPC
ISO 13485
Statistics
Standards
APQP
GMP
Corrective and Preventative Actions
ISO 13485:2003 are
Desired experience for senior supplier quality engineer includes:
Identify and plan training to address gaps in both skills and behaviour
Track supplier quality performance measurement (KPI's) and participate in supplier performance reviews
Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management
A degree concentration in Engineering, Life Science, Physical Science, comparable work experience, or a related field is an asset
Knowledge of ISO and/or cGMP, experience in a FDA regulated environment is preferred
It is required to be able to communicate effectively at all levels within Quality cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing
Senior Supplier Quality Engineer Examples
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Senior Supplier Quality Engineer Job Description
Job Description Example
Our company is growing rapidly and is looking for a senior supplier quality engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior supplier quality engineer
- Have knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics
- Possess knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards
- Establish annual global audit plan for suppliers and maintain oversight
- Participate in internal audits and supplier evaluations
- Work with product support teams, engineering and others on component quality issues and supplier initiatives
- Direct vendor interactions including travel to supplier sites
- Assist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution
- Support the applicable site Quality System
- You will both work within a team and independently
- Project manage SQE activities for S.V
Qualifications for senior supplier quality engineer
- Familiarity with SAP, Windchill helpful
- Willingness to work in an office Budapest, Hungary
- Requires a minimum of four years relevant work experience within the medical device or pharmaceutical industry that includes two years in Quality Compliance Auditing
- Professional audit designation (ASQ -CQA, CBA, AQA, RAB, etc)
- Lead auditor certification is a plus
- Design control and validation experience is a plus
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Senior Supplier Quality Engineer Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of senior supplier quality engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for senior supplier quality engineer
- Help drive the APQP and PPAP processes with selected suppliers
- Lead the FMEA activities as required
- Finalize the APQP process with PPAP approval at the suppliers site with follow up audits to assure a successful production launch
- Have SQE responsibility for S.V
- Conduct component release, process release and PSW in IPD LCM&MLU(life circle management and Middle Circle Update)
- Evaluate existing suppliers
- Participate in supplier audits, supplier evaluation, and supplier monitoring as required
- Evaluate processes, write audit reports, write non-conformances, and store records per Document Control
- Serve as a subject matter expert for supplier evaluations, share expertise within the division and site
- Communicate “lessons learned” from the supply base to R&D for incorporation into next generation designs
Qualifications for senior supplier quality engineer
- This position will be located in Irvine, California and may require up to 30% of both international and domestic travel
- Understanding of change control processes and requirements
- Willing to travel in support of the projects to different geographical locations
- Minimum of 5 years of experience in manufacturing environment or equivalent
- Good knowledge of change control processes in a highly regulated environment
- Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time
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Senior Supplier Quality Engineer Job Description
Job Description Example
Our growing company is looking for a senior supplier quality engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior supplier quality engineer
- Monitor, communicate and improve key supply chain KPI’s, including Supplier OTD (Past due), Quality DPPM, process performance yield, and waste
- Establish specific short / long term supplier quality and OTD goals
- Collaborate with suppliers and extended manufacturing teams regarding performance of product and support the technical team to determine process improvements required to eliminate waste
- Work to resolve supplier technical issues in a timely manner to ensure continuity of supply of goods and services for our customer’s value streams and product development
- Train Suppliers in basic Root Cause/Corrective Action, Process Mapping and Problem solving
- Actively manage suppliers to ensure there are no regressions with the implementation of new processes and corrective actions
- Develop error proofing (poka yoke) strategies collaborating with suppliers
- Assist SQE Manager to monitoring, report and support of supplier quality metrics and performance
- Complement Site Operations in Supplier-related Activities
- Support sites on incoming inspection, problem part resolution through all phases of operations
Qualifications for senior supplier quality engineer
- A minimum of a Bachelor of Science degree is required
- The individual should enjoy working in a dynamic, cross-functional and results oriented team environment focusing on quality, compliance and customer satisfaction
- A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations
- Demonstrated proficiency in relevant PC applications
- Demonstrated ability to manage multiple tasks in a fast-aced, deadline-driven environment
- Bachelor’s Degree in mechanical or industrial engineering, or other related field of study
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Senior Supplier Quality Engineer Job Description
Job Description Example
Our company is looking for a senior supplier quality engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior supplier quality engineer
- Provide Support to Site regarding Site Quality Management System
- Support overall site Quality Management System through metrics, auditing, Mentor and support RI activities and process effectiveness
- Work on special project as requested to resolve problem or productivity improvement
- Initiate and follow up on incoming materials FA request with suppliers
- Perform supplier qualification audits, monitor supplier performance, provide supplier program metrics and periodic reports, and manage the supplier corrective action system
- Serves as the Chairperson on the Supplier Review Committee (SRC) and ensures ongoing supplier program transparency and open communication between cross-functional departments
- Establishes and maintains the Supplier Audit Schedule and ensures compliance with this schedule
- Serves as the supplier quality representative during internal audits and for designated suppliers, as necessary
- Certified or trained to perform quality audits is highly desired
- Drive analysis & conclusions from process performance data from suppliers
Qualifications for senior supplier quality engineer
- Master's degree in Engineering or a Master's in Business Administration
- Bachelor of Science Mechanical or Electrical Engineering from an ABET accredited university
- Bachelors of Science degree in Engineering, Science or other related field
- Minimum of five years of relevant works experience
- ASQ Certification, Certified Quality Engineer or Certified Quality Auditor, preferred
- Competent with Six Sigma tools and application, Green Belt preferred
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Senior Supplier Quality Engineer Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of senior supplier quality engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior supplier quality engineer
- Complete component qualification via PPAP
- Support Quality Team as needed
- Performs product and process evaluations to identify areas for improvement
- Working with the supplier/s ensure that their process capability is established, agreed, understood and monitored
- Collect and evaluate supplier quality data to identify process improvement opportunities within the supply chain
- Regularly communicate with Engineering, Manufacturing Quality, and Procurement internally to identify opportunities for quality and productivity improvement
- Collect and maintain supplier performance metrics.Coordinate with Engineering, Manufacturing and Product Quality to ensure awareness to known purchased part or product quality issues
- Coordinate with Engineering, Manufacturing and Product Quality to ensure that the suppliers capabilities are understood and any gaps in requirements are planned for closure
- Defines Supplier on-site project scope and develops project plans
- Works under minimal supervision, performs wide range of assignments (Specific Audits, Six-Sigma based improvement projects, ) using mature judgment and expertise to develop solutions to specified problems
Qualifications for senior supplier quality engineer
- Experience in a cGMP regulated pharmaceutical and/or medical device environment is required
- Familiar with FDA regulations as they pertain to Sage Products, specifically 21CFR211 and 21CFR820
- Knowledge and skills in quality-related methods, techniques and application including problem solving, process management, assessment and metrics
- AS9100 or MIL-STD experience
- AS9102 FAIR experience
- Degree in Engineering with minimum 3 years related working experience