Supplier Development Quality Engineer Ii Jobs

Requirements (knowledge, Skills & Abilities)

Will adhere to all quality requirements that are inside of the Quality Management system.

EDUCATION AND EXPERIENCE (required Levels)

Maintaining constant communication with supplier to ensure all quality requirements are being meet. Example: Heat Cert, DoC, packaging standard.

Coordinate with Supply Chain (local and/or global) & Engineer on new component supplier qualifications and any new supplier approval.

Manage the New Supplier approval process according to the QMS.

Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.

Spine & Biologics, offers procedural solutions for spine surgery, and bone grafting solutions for spinal fusion. 

US and International travel requirement: Less than 10%

China Cranial, Spinal, Orthopedics & Technologies, provides solutions in spine surgery, neurosurgery, surgical synergies, biologics, and orthopedics.

Define and maintain statistical thresholds for complaint monitoring. Execute post market trending process.

Collaborate with cross-site Post Market Quality, Regulatory Affairs, and Engineering to support and author pre- and post-market product risk assessments.

Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.

Spine & Biologics, offers procedural solutions for spine surgery, and bone grafting solutions for spinal fusion.

US and International travel requirement: Less than 10%

China Cranial, Spinal, Orthopedics & Technologies, provides solutions in spine surgery, neurosurgery, surgical synergies, biologics, and orthopedics.

Define and maintain statistical thresholds for complaint monitoring. Execute post market trending process.

Collaborate with cross-site Post Market Quality, Regulatory Affairs, and Engineering to support and author pre- and post-market product risk assessments.

Coach Supplier Operations Team members on Quality Management System requirements and best practices

Demonstrated knowledge of quality management methodologies such as:

Site Operations to include, Manufacturing, Quality, Engineering, Program Management

Strong interpersonal skills with excellent written and verbal communication (Technical Writing experience a plus)

Problem solving, analytical, and process improvement skills / experience

Lead activities such as Supplier qualification, Supplier development, and Supplier Zero Defect Programs (ZDP)

Proficient in project management, analytical, critical thinking, problem solving and prioritization skills

Establish new initiatives to support ongoing improvement of Supplier Quality Management Systems

Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820

Excellent people interaction, team building, leadership, and communication skills including providing effective presentations.

Demonstrate innovative and implementation skills

Demonstrate knowledge of Statistics and Data Analysis to drive data based results and decisions

12% 401k Match + Other Generous Benefits|Fortune 500 Company

Participating in cross-functional teams to evaluate and select new suppliers, ensuring that they meet the company's quality requirements.

5+ years of experience in supplier quality engineering in the electronics manufacturing industry

Experience with supplier audits, corrective action plans, and continuous improvement initiatives

Strong analytical and problem-solving skills

Excellent communication and collaboration abilities

Defines product qualification strategy in alignment with D&E and Manufacturing Engineering

Arranges and control supplier interface processes, such as issue resolution, root cause analysis, qualification, deviation, ASML factory disturbances.

Can learn and apply new information or skills.

Quality, to secure the level of industrialization required to manufacture this part with zero defects in high volume.

Secures (NPI) first time right into the ASML factory or customers.

Defines the complex parts list with Technology Gaps enabling supplier selection with sourcing.

Must have 2 years of experience in Quality Engineering

Strong communication, collaboration, and problem-solving skills are required.

Both, FDA, and ISO regulations knowledge is required.

Strong root cause analysis skills are required.

Operations supplier quality experience is preferred.

Experience in the medical device and/or pharmaceutical industry is preferred.

Responsible for management of change, controlling revision level and coordinating inventory readiness and change point management

Remote but must live near an airport. Travel - 50%

Drive supplier selection through robust qualification process.

Research external markets (domestic and international) to identify potential sources and suppliers.

Minimum of 5 years of experience in an engineering, quality or Manufacturing related position.

• Ability and Knowledge to conduct Root Cause Analysis through various industrial techniques. 8D, A3, DMAIC …ect.

• Experience in the development and execution of standard operating procedure documents.

• Knowledge of GD&T standards and implementation.

Click here to learn more about LTTS-

• Proficient in Microsoft Applications, word, excel ect..

Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.

Lead and manage complaint investigations.

Coordinate and lead preparation of Quality Plans including inspection, test and gauge requirements for new product introductions.

3+ years’ experience in medical device or other regulated manufacturing industry Bachelor’s Degree in related field.

Strong communication skills and ability to align with key stakeholders.

Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

Proven ability to manage projects and suppliers to requirements and standards.

Knowledge of IPC standards (IPC-A-610, Acceptability of Electronic Assemblies, IPC/WHMA-A-620B Requirements and Acceptance for Cable and Wire Harness Assemblies)

Conduct supplier audits and assess supplier capabilities and capacity to perform current and/or future work.

Experience working with ISO quality standards and other Aerospace standards, AS9100,

Knowledge of Electromagnetic Interference (EMI) and Electromagnetic Compatibility (EMC) considerations with respect to electrical/electronic design (e.g., wire harness design, grounding and

Knowledge of manufacturing processes, materials science, and prototyping techniques

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks -

BS degree in a related engineering discipline with 0-2 years of relevant experience or a Master’s Degree

Effective communication skills (verbal, written, presentation)

Knowledge of Quality Systems (eg: cGMP, FDA 820 QSR, ISO 13485) is a plus

Knowledge of statistics, Six Sigma, Lean is a plus

Exact compensation may vary based on skills, expertise, and location

Conducting audits of suppliers. Auditing experience is required.(Experience in standard with ISO 90001 is a requirement)

Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 as they will be auditing according to those standards.

Bachelor's degree in Engineering or Technical Field or equivalent experience.

Minimum 4 years of related experience is required.

Maintain approved supplier list: Addition of new suppliers, qualifying new suppliers, and monitoring the performance of current suppliers.

Must e able to handle 15 to 16 audits in a year.

B.S. in engineering or an alternative bachelor’s degree program with certification as a quality engineer (e.g. CQE).

Minimum 1 year of relevant work experience.

Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred

Formulates procedures, specifications, and standards for Zimmer products and processes.

Develops and implements corrective/preventative action plans.

Collects and analyzes data for gauge and product evaluation.

Lead the development, modification, and maintenance of processes for supplier qualification & certification, assessment, monitoring, escape management, and quality issue resolution.

Act as an internal consultant for root cause analysis & problem-solving (Red-X & 8D) in escape management procedures.

Bachelor’s Engineering, Operations Management, Supply Chain, or Business

5 years plus of strategic experience in Manufacturing, Quality, Supply Chain, or Supply Chain Sourcing

5 years plus experience in Supply Chain/Sourcing in Supplier facing activities

Other qualifications you may have that would be beneficial in this role include:

Communicate concerns and successes of supplier quality management up the chain to upper management

Rapidly growing global manufacturer with competitive compensation|Demonstrate complex problem solving skills in an employee first environment

Demonstrate problem solving skills to identify and correct issues in a timely, yea effective manner

Assist Purchasing group in the evaluation and qualification of new suppliers

5+ years of experience (preferably in supplier quality)

Rapidly growing global organization with opportunity to join new team

Bachelor’s degree, Engineering, Quality Management, or related field and/or equivalent combination of education and experience

Ensuring correct nonconform and suspected product management

Minimum 3 year of relevant experience in a manufacturing environment

Knowledge of quality tools and methodologies (8D, 5WHY, Statistical Tools, SPC, etc.)

Excellent PC skills with the ability to produce high quality document deliverables in short time scales

SAP knowledge, desirably with quality module

2.3-5 years of proven experience in manufacturing and in securing vendor contracts.

4.Excellent statistical analysis and quality assurance skills.

5. In-depth knowledge of the technical aspects of manufacturing and engineering.

6. Good working knowledge of quality control standards and government compliance.

7.Experience with manufacturing and production processes and engineering principles.

9. Excellent communication and English skills.

Familiarity with quality management and planning tools

Advanced experience with MS Excel. Minitab preferred

US Employees may be eligible for the following benefits:

Health Care and Dependent Care Flexible Spending Accounts

Business Travel Accident and Business Travel Health

Flexible Time Off, Paid Holidays