VCC Job Search Support Group: Fwd: FW: [B2DG] THREE MORE POSITIONS; 2 ENGINEERING AND 1 MANAGER

Subject: [B2DG] THREE MORE POSITIONS;

Below are three more job openings available at a Bay Area medical device company from a recruiter I've worked with. If any of these positions might be a fit for you, contact

Harris Recruiting LLC
Tammy Harris / Placement Director
Office: 205-421-1772
Fax: 205-629-3068
Cell: 205-616-7946
harrisrecruiting@ windstream. net

POSITION 1: Quality Manager II

GENERAL SUMMARY:
The Quality Compliance Manager is responsible for the administration, supervision, and development of the Electrophysiology Quality Compliance Department.

SPECIFIC DUTIES AND RESPONSIBILITIES:
„h Establish and support a work environment of continuous improvement that supports BSC¡¦s Quality Policy, Quality System and the appropriate regulations for the area supported. Ensure employees are trained to do their work and their training is documented.
„h Provides significant guidance and approval regarding quality system strategies and approaches.
„h Develops guidance and training to staff, assists subordinates in attaining career goals, motivate individuals to achieve results, and recruits and maintains a high quality staff.
„h Determines appropriate staff levels, schedules and resources to contribute to overall organizational success.
„h Policy/procedure writing to ensure local regulatory compliance according to all applicable quality and regulatory standards, regulations, and BSC corporate policies.
„h Manages the following functions: CAPA, Complaint/MDR Processing/reporting, Internal Auditing, Quality Systems Review Board, for each of these areas, develop and maintain periodical trending reports. Provides overall trending data and participates/conducts Management Review. Acts as liaison and contact to external auditing agencies
„h Ensure the General Training requirement of Introduction to Quality System is delivered to for new employees as part of the New Hire Orientation.
„h Drive quality projects by evaluation and implementation of new processes and technologies relating to improving quality system management
„h Work cross-functionally and cross-divisionally in identifying and resolving technical issues.
„h Develops and monitors department budgets.

POSITION QUALIFICATIONS:
10 ¡V 14 Years experience in medical device quality with BS or equivalent and 5 years of supervisory experience; or equivalent combination of education and experience to perform at this level.

POSITIONS 2: Senior Manufacturing Engineer (Polymer/Plastics)

SPECIFIC RESPONSIBILITIES:
Leads and/or participates in project teams coordinating the efforts of engineers, technicians and other professionals of various disciplines/departments to design, develop, and continuously improve product, equipment, fixture processes. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total project of moderate scope. Performs work which involves conventional engineering practice but may include a variety of complex features such a conflicting design requirements, unsuitability of standard materials, and difficult coordination requirement. Performs engineering work typically including one of the following: process/product improvements, test of materials, preparation of specifications, process study, evaluation of process models/process improvements, product design, development improvement of equipment, tools, fixtures, report preparation, and other activities of wide scope requiring broad knowledge of precedents in medical device design and development and good knowledge of principles and practices of related specialties. Interfaces with vendors and other outside specialists. Participates in Quality Circle (REFINE) activities. Audits, investigates, tests, and evaluates external process technologies. Performs responsibilities required by the Quality System and other duties as assigned or requested.

REQUIREMENTS:
B.S. in Engineering (mechanical/electrical preferred) plus minimum 5-8 years of engineering experience in a manufacturing environment, minimum of 2 years experience in an FDA regulated manufacturing environment required. Or equivalent combination of education and experience. Proficiency with Medical Device development life cycles and manufacturing processes and technologies preferred. Knowledge of FDA regulations

POSITION 3: Senior Manufacturing Engineer (Six Sigma)

SPECIFIC RESPONSIBILITIES:

Leads and/or participates in project teams coordinating the efforts of engineers, technicians and other professionals of various disciplines/departments to design, develop, and continuously improve product, equipment, fixture processes. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total project of moderate scope. Performs work which involves conventional engineering practice but may include a variety of complex features such a conflicting design requirements, unsuitability of standard materials, and difficult coordination requirement. Performs engineering work typically including one of the following: process/product improvements, test of materials, preparation of specifications, process study, evaluation of process models/process improvements, product design, development improvement of equipment, tools, fixtures, report preparation, and other activities of wide scope requiring broad knowledge of precedents in medical device design and development and good knowledge of principles and practices of related specialties. Interfaces with vendors and other outside specialists. Participates in Quality Circle (REFINE) activities. Audits, investigates, tests, and evaluates external process technologies. Performs responsibilities required by the Quality System and other duties as assigned or requested.

REQUIREMENTS:

B.S. in Engineering (mechanical/electrical preferred) plus minimum 5-8 years of engineering experience in a manufacturing environment, minimum of 2 years experience in an FDA regulated manufacturing environment required. Or equivalent combination of education and experience. Proficiency with Medical Device development life cycles and manufacturing processes and technologies preferred. Knowledge of FDA regulations