Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Our client is a leading contract manufacturer of high-performance, precision components for demanding medical device applications. They offer customers extensive global manufacturing expertise, by combining lean manufacturing and continuous improvement with advanced process technology. Their decades of DFM and lean-manufacturing experience provides our OEM partners a single-source solution - from design and development input through the manufacturing process to the flawess completion of a project ? adding value at every step.
Works within a manufacturing environment and is charged with developing, implementing, maintaining, and improving a quality system to assure that all products manufactured by the organization meet customer specifications and achieve superior quality, reliability, and value for the customer. Provide quality assurance support, guidance, and leadership to the company to achieve quality goals and objectives, and to promote and uphold the high expectations for quality and continual improvement.
DUTIES AND RESPONSIBILITIES
? Responsible for maintaining and improving established Quality Systems according to FDA 21CFR820 Quality System Regulation and ISO 13485 requirements to ensure that customer product quality and customer requirements are met. This includes responsibility as the management representative for the quality system.
? Collaborates and works closely with the General Manager and peer managers in Engineering, Manufacturing, Product Areas, and Purchasing to support manufacturing and activity to achieve quality goals and objectives.
? Ensures that the Quality Department is staffed at appropriate levels through planning, forecasting, developing manpower plans, and departmental budgets.
? Provides clear direction to direct reports and obtains results using a participative management style.
? Primary interface with customers with respect to all quality related issues, and quality systems audits.
? Responsible for proper coordination of the Correct and Preventive Action process for CAPA?s stemming from audits, customer complaints or other sources.
? Provides valuable input during contract review process related to ability to meet customer requirements, inspection methods and required inspection equipment.
? Prepares in preparation of quality plans, procedures, scheduling, staffing plans, etc.
? Assist product areas in maintaining control of non-conforming product including ensuring proper identification, inventory control, and quick disposition of suspect material.
? Coordinates the activities of Gage Calibration, Quality Engineering, Internal & Customer Audits.
SPECIFICATIONS (SKILLS AND ABILITIES)
? Strong interpersonal and presentation skills needed to interact with customers as well as with all levels within the company.
? Thorough knowledge of machine processes and statistical process control.
? Must demonstrate excellent writing skills with ability to prepare technical documentation.
? Thorough knowledge and experience surrounding quality control inspection equipment and methods, including calibration and fuctionality.
? 7+ years of Medical Device experience in a quality role.
? Bachelor?s Degree in an Engineering discipline
? Proven problem solving experience, including 8D
? Proven management and leadership skills.
- Quality Inspector in Fridley MN
- CNC Machinist Mill or Lathe in Boylston MA
- Manufacturing Engineer in Newnan GA
- Order Processing Admin in Billerica MA
- Multi-Purpose Technician in Flowery Branch GA
- Maintenance Technician in Lawrenceville GA
- Machine Watcher - Technician in Woburn MA
- Material Handler in Franklin MA
- CAD Designer in Atlanta GA
- Fabricator - Insulation Shop in Loganville GA
- Maintenance Technician in Loganville GA
- Field Service Technician in Loganville GA
- Receiving Material Handler in Flowery Branch GA
- Equipment Operator in Jefferson GA
- Bench Service Technician in Alpharetta GA
- Quality Control Inspector in Cumming GA
- Shipping-Receiving & Inventory Control Clerk in Cumming GA
- Logistics - Dispatch Manager in Everett MA
- Product Designer in Conyers GA
- Sr. Manufacturing Engineer in Keene NH
- Mechanical Assembler in Duluth GA
- SENIOR ID-OD GRIND MACHINIST in Central Manchester CT
- Maintenance Supervisor in Seabrook NJ
- Electrical Engineer in Brooklyn Park MN
- Quality Tech 1 in Memphis TN
- Trade Operations Supervisor in Milford MA
- Standard Fabrication - FC Prep2nd Shift in Suwanee GA
- District Manager in Los Alamitos CA
- Sr. CNC Machinist in Memphis TN
- Shipper-Receiver in Memphis TN
- Quality Inspector in Brooklyn Park MN
- Electrical Tester in Brooklyn Park MN
- Control Panel Power Wirer in Brooklyn Park MN
- Control Box Builder in Brooklyn Park MN
- Wire Harness Assembler in Brooklyn Park MN
- Warehouse- Receiving Associate in Lawrenceville GA
- Machine Operator - 2nd Shift in Newton MA
- Senior Programming Engineering in Contoocook NH
- Modular Assembly - 2nd Shift in Suwanee GA
- Mechanical Design Engineer in Lawrenceville GA
- CNC Machine Operator (2nd shift) in Ashland MA
- Manufacturing Engineer in Pendergrass GA
- Assembly Line in Flowery Branch GA
- Bricker II in N. Billerica MA
- Sheet Metal Fabricator (Mechanic) in N. Billerica MA
- Production Assistant in Los Alamitos CA
- 3rd shift Electro-Mechanical Manufacturing Technician in Andover MA
- Sr.-Staff Software Engineer in Andover MA
- Buyer - Planner in Merrimack NH
- Sr Systems Engineer in Bedford MA
- Assembler II in Milford MA
- Sr. CNC Machinist in Memphis TN
- Wiring Technician in Hoschton GA
- Fabricator in Flowery Branch GA
- Material Handler in Eden Prairie MN
- CNC Machinist-Programmer - Level 2 in Suwanee GA
- ASRS Machine Operator - 3rd Shift in Suwanee GA
- Assembly Technician in Billerica MA
- Shipper-Receiver in Woburn MA
- Buyer in Milford NH
- Production Supervisor in Brooklyn Park MN
- Electrical designer in College Park GA
- Project Engineer in College Park GA
- Controls Automation Engineer in Maple Grove MN
- Slitting - 3rd Shift in Suwanee GA
- Slitting Lead - 3rd Shift in Suwanee GA
- Facility Mechanic in Plymouth MA
- Wire Harness Assembler - Solderer in Wilsonville OR
- Control Panel Power Wirer in Wilsonville OR
- Control Panel Point to Point Wirer in Wilsonville OR
- Shipping - Lead in Suwanee GA
- SENIOR QUALITY SPECIALIST in Merrimack NH
- Electrical Design Engineer in Huntsville AL
- Picker-Packer in Memphis TN
- Assembler III in Hudson NH
- Jr. Program Manager in Hudson NH
- Shipper-Receiver in Marlborough MA
- Electrical Tester in Brooklyn Park MN
- Manufacturing Test Engineer in Huntsville AL
- Controls Engineer in Newnan GA
- Purchaser in Duluth GA
- Test Technician in Duluth GA
- CNC Programmer in Memphis TN
- Industrial Maintenance Mechanic in Memphis TN
- Quality Inspector in Memphis TN
- CAD Designer in McBee SC
- Inside Sales Representative in Golden CO
- Design -Drafter in Concord NH
- Quality Assurance Technician in Lawrenceville GA
- Marketing Program Manager III in Lowell MA
- Assembler in Derry NH
- Forklift - Warehouse in Suwanee GA
- Machine Operator - 2nd Shift in Middleboro MA
- Stock Prep Position in Middleboro MA
- Assembler (1st Shift) in Middleboro MA
- Quality Assurance Inspector in Flowery Branch GA
- CNC Machinist in Milford MA
- Service Tech - Installer in Suwanee GA
- Maintenance Technician in Hickory NC
- SMT Machine Operator in Milford NH