BD (Becton, Dickinson and Company) IQC Supervisor in Humacao,

Job ID: 2018-12272

Career Level: management

Relocation: no

Location: HUMACAO,Puerto Rico

Overview:

The IQC Supervisor provides direct supervision to the incoming inspection personnel and assures the effective use of all the resources to meet goals and requirements set forth by the Company and by Regulatory entities. Such requirements include, but are not limited to: Safety, Quality, GMP, ISO 13485, and Housekeeping standards. The IQC Supervisor is also responsible for providing technical support and improving processes to minimize cost, and increase productivity. Must be able to prepare projects plans. Will be a leader for Lean Manufacturing Implementation. Shall be capable of managing difficult inspection processes problems through a well and sound solution methodology.

Summary of Position with General Responsibilities:

Essential Job Functions:

  • Supervises personnel in incoming inspection area to assure control, adherence to safety, quality, and schedule requirements

  • Assures adequate employee training and compliance to Regulatory and Company requirements and polices

  • Maintains direct contact with other departments to resolve issues on a day to day basis. Provides Liaison between Engineering and Supplier representative in key quality issues

  • Keeps records and issues reports as required to document the performance of the area supervised and to keep management informed of overall performance

  • Participates actively in various Company programs (Lean Thinking, CIP’s, etc) geared to optimize performance, reduce costs and meet regulatory requirements

  • Evaluates performance and administers the disciplinary procedure where applicable

  • Supports incorporation of new technology where feasible and practical

  • Supports and coordinates the implementation of Lean Manufacturing strategies. Assists in identifying and eliminating Non Value Added Activities

  • Reviews inspection, labeling, and release logistic for appropriate process flow and documentation.

  • Updates drawing, inspection procedures and any other documentation needed to inspect, test or purchase products

  • Assists in establishing annual tooling and capital investment budgets, selects, proposes and justifies less-experienced department personnel

  • Motivates, manages and develops personnel in a team environment

  • Uses the required clothes, personal and security protective equipment

  • Complies with the cGMP's, Quality Standards and established policies and/or procedures

  • Develops, establishes and monitors supplier’s compliance with post validation agreement.

  • Develops, establish and continuously improve the necessary controls at the supplier to minimize incoming inspections.

  • Develops and establish the system to standardize inspection methods with suppliers.

  • Oversees supplier quality metrics including but not limited to first pass yield. Collect and analyze data to track improvement and develop appropriate corrective actions.

  • May identify, initiate and drive scrap-reduction and cost-savings projects related to supplier quality issues.

  • Performs internal audits to verify compliance with cGMP’s, and applicable ISO standards.

  • Works with Supply Chain management to drive supplier process and materials compliance with international regulatory requirements (i.e RoHS/WEEE, etc.)

  • May aid in the resolution of product complaints related to failure of components at the supplier specifications level.

  • When needed, assists the Supplier Quality Engineer in activities including, but not limited to, SCAR Management, Supplier Assessments (Performance Evaluations/On-Site Audits), Supplier File Maintenance, and Component Qualifications.

  • Establishes a direct communication with the supplier to inform and discuss Bard’s requirements in order to maintain the supplier in the approved vendor list.

  • •Executes other duties assigned by Supervisor

Basic Qualifications:

  • Must have knowledge of cGMP’s, OSHA, QSR and ISO 13485

  • Must be able to utilize Lean Manufacturing / Six Sigma tools to resolve product/process issues.

  • Must be able to use problem solving techniques or root-cause analysis tools to solve product/process issues.

  • Must be able to read, interpret, and understand technical and non-technical documents, including but not limited to: contracts, product drawings, and product specifications.

  • Must be bilingual (English and Spanish) and have strong verbal and written communication skills and must be able to successfully interface with technical and non-technical personnel such as inspectors, designers, buyers, vendors, manufacturing personnel and management.

  • P.C. Literate

  • Teamwork oriented

  • Excellent analytical, organizational and interpersonal skills.

  • Must able to travel at least 25% of the time.

  • Metrology and GD&T experience preferred.

  • Certified Lead Auditor in ISO 13485 preferred.

Additional Desirable Qualifications Skills and Knowledge:

Additional Desirable Qualifications Skills and Knowledge:

JDE System knowledge

Education and/or Experience:

Education and/or Experience:

  • Bachelors Degree in Engineering, Business or the Sciences

  • Three (3) or more years of experience as a Quality Supervisor or Engineer, preferably with experience in the Medical Device and/or Pharmaceutical Industry.

Work Environment:

Work Environment:

  • Hours of operation are flexible and vary depending on job requirements. Typical work week is 40 hours with additional/variable hours for specific work periods and projects. Specific work days and hours are flexible and may change with advance notice

  • The nature of the work requires exposure to chemicals, noise. Exposure to machinery and non-ionizing radiation.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status