Supplier Quality Engineer II - P22-021
Job Description
Job Description:
Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.
We are looking for a Supplier Quality Engineer II to join our team. As a uniquely qualified candidate, you will be responsible for production planning and inventory control for multiple products while prioritizing operations to ensure maximum performance and minimum delay. This individual will take a lead role in continuous improvement, product flow and capacity improvement to improve the overall efficiency of manufacturing while service level targets.
SUMMARY: Performs planned and unplanned Internal and supplier audits to verify compliance to applicable government regulations, standards and to company policies and procedures. Maintains Supplier Quality requirements and supports Quality Systems within Confluent Medical such as Training, Customer audits and Document Control. Recommends improvement to quality systems based on assessments performed. Provides compliance guidance to the organization as required including guidance to lower-level personnel. Exercises judgment within defined procedures and practices to determine appropriate action. Participates in decisions on scope of work and length of tasks. Writes, reviews, documents, and implements requirements. Provides and develops solutions to problems. Works independently on routine tasks and needs supervision to resolve some complex issues. Supports administration of the SCAR and CAPA system.
SCHEDULE: Monday - Friday 8:00 am to 5:00 pm.
ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.
Performs planned, internal and supplier audits of product and service suppliers for compliance to applicable government and international regulations and company procedures
Assures that the supplier quality system audit function complies with QSR/GMP and ISO requirements
Assigns actions or Corrective actions for deficiencies as needed and required
Assigns classifications and documents audit results in written audit reports
Can serve as lead auditor, leading a team of auditors, technical experts and auditors-in-training
Performs Supplier Module administration for ETQ Reliance software
Work with Supply Chain department to maintain supplier profiles up to date
Subject Matter Expert for Supplier Management QSE section
Reviews audit responses and assist with required training in response to audit findings and other GMP/QSR/ISO related issues as needed
Periodically collects compliance metrics and generates data for management reviews
Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings
Responsible for following all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Support Regulatory Affairs processes, including submission of product 510K and Design Dossier
Works with supply chain to ensure Supplier Change Notifications are implemented as planned in Confluent´s system
EDUCATION and/or EXPERIENCE:
Bachelor's degree in engineering discipline; with 2-3 years of related experience (Required).
English B2+ minimum (Required).
Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of relates specialties.
Experience and knowledge in Process Validation in the Medical Device Industry would be an important asset.
Knowledge of audit and statistical techniques is a must.
OTHER SKILLS and ABILITIES:
Good written and oral English communication skills.
Ability to conduct external audits and communicate with external parties.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to use PC's and associated software.
Ability to effectively interface with governmental and independent auditors.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to write speeches and articles for publication that conforms to prescribed style and format.
Ability to effectively present information to top management, public groups, and/or boards of directors.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collects data, establishes facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
COMMENTS: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all‑inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.