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Location: Taunton / Wareham area…local candidates only

This client is well established, profitable and expanding. They are implementing LEAN and looking to hire someone who can champion a LEAN philosophy and facilitate the development of a new culture. 

Oversee all facets of quality in a LEAN environment: Quality Management System, Inspection, ISO Management and Customer Returns. This is hands on role managing one engineer and a few inspectors. 

Responsible for promoting quality based, process driven policies, procedures and metrics including product development, vendor quality programs, and manufacturing operations. 

· Quality management system established, implemented and maintained. 
· Periodic reporting to top management 
· Ensuring company awareness of customer requirements 
· Perform random inspections of production 
· Ensure effective methodologies for maintaining and improving product quality.
· Manage non-conforming materials system; assess material and process defects and implement corrective action
· Continuously pursue supplier quality improvements 
· Maintain ISO certification
· Travel to customer and vendor sites (up to 25%)
· Assist with LEAN manufacturing implementation
· Prepare and present training

Qualifications

· BS degree 
· 7+ years of progressive experience in Quality Assurance with 3 years a Quality Manager 
· Comprehensive knowledge of quality assurance practices and process and tools
· Impressive record of championing, training and utilizing LEAN & 6 sigma
· Previous ISO certification, audit and improvement experience 
· Demonstrated computer (spreadsheet & database) know-how 
· Significant experience in Six Sigma, TQM, ISO and Lean
· In depth knowledge of lab procedures including measuring/inspection instruments, test and auditing equipment
· A catalyst able to teach, train and empower employees to embrace a continuous improvement, constant waste elimination culture
· Ideal industry experience: high tolerance, very precise mechanical and / or instrument assembly

Compensation: base salary can go into the low 100’s 

Contact:
Leslie Gabriele
Gabriele & Company 
Recruiters for Manufacturing and Materials

www.gabrieleandcompany.com
781-276-7999
leslie@gabrieleandcompany.com
http://www.linkedin.com/in/gabrieleandcompany

Posted 7-19-10

 Quality Engineer 

LOCATION: Cranston, Rhode Island 

RESPONSIBILITIES: 
· Interfaces with Sales, Engineering and Manufacturing within the company and with customers and on quality-related issues. Analyzes specifications and drawings to identify potential quality problems and initiate changes to internal documents as appropriate. 
· Conducts product experiments and statistical process capability studies to understand and determine the causes of variability. Has an intimate responsibility with the First Article Inspections and Process Validations (IQ/OQ/PQ) during product launch and subsequent changes to tooling or specifications. Collects, analyzes and distributes statistical data and summary reports.
· Develops inspection methods and product specifications for use by technicians and inspectors during production. Directs workers engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability. Interprets inspection requirements for Inspection and Manufacturing personnel.
· Works with Manufacturing and Quality Inspectors to contain and disposition non-conforming product. Troubleshoots and participates in solving quality-related production problems. Takes a lead role in facilitating and aiding in scrap reduction initiatives. Collaborates with Design and Manufacturing Process Managers to establish manufacturing standards and determine allowable deviations from specifications. Recommends design and processing revisions to reduce actual or potential quality costs. 
· Collects and distributes customer complaint data and other process metrics. Organizes containment activities and coordinates investigation for non-conformances, complaints and corrective actions. Facilitates corrective action and root cause problem solving activities, and takes a primary role to ensure countermeasures are effective. 
· Performs Internal Quality Compliance Audits as assigned and monitors effectiveness of corrective actions.

QUALIFICATIONS: 
· 3-5 years of Quality Engineering experience in a Manufacturing environment including validation and measurement analysis or combination of education and experience.
· BS, AS in Engineering or equivalent is preferred. ASQ CQE highly preferred
· Good math and PC skills. Working knowledge of statistical software, Minitab preferred
· Excellent organizational and oral / written communication skills are required 
· Thermoforming and/or packaging experience a plus

If interested please send resume Human Resources Department, 301 Mayhill Street, Saddle Brook, N.J. 07663 c/o Nadine Maffucci, or Nadine.Maffucci@sealedair.com.
Posted 7-7-10

  Quality Specialist 

JOB LOCATION – Moosup, CT

RESPONSIBILITIES - Quality Inspector, experience with Verniers, calipers, height gages, all measuring tools. Prior experience in the Aerospace/Defense Industry, directly related to Product Certification of Compliance (Certs), Lot Acceptance Test Reports, Working from MRB's from initiation to closure, Coordination of LAT schedules w/customers, Shop Floor support. The majority of the activity involves assembling paperwork into quality documents supporting shipment of product In addition candidate will be interacting with numerous people, hourly producers, management and customers, in person, via phone and email.

QUALIFICATIONS 5+ years in quality inspection and documentation.

CONTACT – Jon Strouch
U.S. Engineering Technical Services, Inc.
800 446 9703
jstrouch@usets.com
Posted 7-7-10

 Quality Engineer 

JOB LOCATION Warwick, RI

RESPONSIBILITIES: Our client is looking for a degreed Quality Engineer to start ASAP. Looking for a candidate that is an expert in part and component qualification. Components made of molded, machined, and extruded components. Must be able to perform CPK analysis and must be able to do statistical analysis. 

QUALIFICATIONS: Medical or Automotive Industry experience/Quality Engineer

CONTACT:

Lauren Gablinske, Technical Recruiter at Summit-Technical lgablinske@summit-technical.com or 401-738 9097, Ext 1044
Posted 7-7-10

 Quality Control Supervisor 

MicroGroup is a rapidly growing contract manufacturer serving the medical device industry with facilities in Medway, Massachusetts and Bethel, Minnesota.

MicroGroup is full service, offering cut "to order" and finished precision metal tubing for medical and industrial applications, as well as full, end-to-end project support for machined medical device components. Our machining capabilities include milling, turning/Swiss turning, grinding, lapping, honing and EDM. An ISO 9001:2000-registered company, we take quality seriously. We know what’s on the line. And that’s why we succeed. We have the passion to improve lives and make a real difference.

The following position is available at our Medway, MA facility:

JOB DESCRIPTION: Quality Control SupervisorAs a key member of the Quality team, The Quality Control Supervisor will ensure customer success by providing high quality products and services while focusing on continuous improvement. This position is accountable for managing Inspection, and supervising and developing a staff of Inspectors, Quality Technicians, and a Documentation Control Clerk. The Quality Control Supervisor will be a strong advocate for Quality while providing innovative manufacturing solutions to the MicroGroup team and customers.

DUTIES AND RESPONSIBILITIES:

· Manage Quality Control Department to include monitoring performance of Inspection functions.

· Provide technical assistance for gaging set ups and interpretation of customer blueprints.

· Provide training to staff to improve technical abilities and competence.

· Distribute incoming, inprocess, or final inspection materials.

· Determine validity of customer complaints via customer contact, blueprint interpretation, and/or inspection of returned goods.

· Organize and schedule inspections.

· Act as a liaison for all matters relating to the quality of finished goods.

· Maintain and report product conformance to engineering and customer specifications through inspection of raw material, work in process, and finished goods inventory.

· Review the production process for conformance to quality standards.

· Report/track any significant deviations from quality standards and recommending corrective action as necessary to management.

· Visit customer sites to determine quality requirements and gather feedback on current level of customer quality perception.

· Establish and present regular training sessions for inspection and manufacturing employees on quality issues.

· Develop programs to encourage each employee to perform quality control as a part of their operation.

· Participate in new product development to ensure proper quality assurance and control plans can be implemented prior to beginning manufacturing.

· Visit material and component suppliers to review quality concerns and issues in an effort to minimize inspection requirements at the corporation’s business level.

· Recommend and implement new testing equipment.

· Perform other duties as required

REQUIREMENTS:·

 BS in Engineering, Science or related field required.

· 5 years of supervisory experience in a machine shop environment preferred. 

· Certification in ASQ preferred.

· Knowledge of CNC Machining including Citizens, EDM Wire, Welding, Centerless Grinding, Drawing, Metallurgy preferred

· Experience in medical device industry preferred. 

· Experience with lean manufacturing; Six Sigma Certification preferred.

· Knowledge of FDA / CFR and experience with ISO 9000 / 13485 environment required.

· Demonstrated experience developing and presenting training programs required.

· High proficiency in data analysis including statistics, CPK, validation.

· Proficient understanding of measurement techniques, blueprint reading, and strong math skills required.

· Demonstrated experience with MRP systems, quality databases, inspection and control plans.

· Excellent understanding of internal and external customer commitment.

· Strong attention to detail, analytical and problem solving skills required.

· Strong written and verbal communication skills including the ability to communicate and present technical information.

· Ability to travel up to 15%

· Ability to work independently in a hands on, fast paced, high growth, team environment with a sense of urgency.

MicroGroup offers comprehensive benefits that include health, dental, vision, life and disability insurance, 401(K), flexible spending accounts, wellness initiatives, tuition reimbursement, employee assistance program, vacation time, holidays, time off. Please visit our website at http://www.microgroup.com for additional company information. 

Resumes may be submitted to careers@microgroup.com

MicroGroup
7 Industrial Park Road
Medway, MA 02053
Fax 508-533-5691
Posted 7-7-10

 Validation Coordinator 

This position reports to the Manager of QA and Education. Coordinates all validation activities in the Donor Services Department including Patient Services, Cord Blood and Therapeutics Programs. This position also manages all Document Control functions for the Department. 

ESSENTIAL FUNCTIONS

· Works with the Director and Manager Education/QA to establish goals and validation plans for changes or additions to operations. This includes:
- Develop and write validation procedures following FDA guidelines. Coordinates validation acting as administrator for SafeTrace software systems.
- Design validation test plans, execute/oversee execution by other Donor Services staff members, present validation documentation to Management.
- Develop and maintain RIBC Process Flow Charts, oversee change control, perform Risk Assessments, Installation Qualification, Operational Qualification, and Performance Qualification as appropriate.
· Collaborate with QA/Compliance, IT and other Donor Services Managers regarding SafeTrace, change control and validation activities.
· Conduct and monitor training for SafeTrace, data conversion and other related computer functions for Donor Services Department, to include training of Customer Service Representatives.
· Assist with maintenance, review and follow-up of Quality Program for Donor Services Department to include all document control activities. Remain current in knowledge of guidelines and developments within the regulatory agencies (A.A.B.B., FDA, O.S.H.A.). Maintenance of QC, tests and recordkeeping, with statistical reports and graphs as assigned. Perform quarterly QC activities. Assist the Education/Quality Assurance Coordinator with performing daily QA review of deferred and collected donor records to include quarantine procedure, release of units, following up with donors and staff as needed, and completing data entry of Error Management Statistics.

EDUCATIONAL REQUIREMENTS:

AS in related field with a minimum of three (3) years of blood banking or related technical experience; or BS in related field. Eligibility for ASQ certification required.

EXPERIENCE/QUALIFICATIONS:

Knowledge and experience with validation of process, software and equipment. 3-5 years of relevant work experience in a regulated environment. Demonstrated educational, quality control, problem solving and analytical skills. Must be able to delegate and follow up with good result, while managing projects. Attention to detail a must. Able to work independently and meet deadlines.

COMPUTER SKILLS:

Working knowledge of Microsoft Office Applications.

Info and how to apply online:
http://www.ribc.org/inner/career.shtml

Posted 7-7-10

Responsible for ensuring corporate compliance with the FDA, the Director of Quality assists in formulating of company policies and the development of long-range quality system goals and objectives. This executive will:

· Oversee Quality management system that complies with the Food and Drug Administration 
· Manage Document control, quality control, internal quality auditing, complaint handling, customer audits, supplier programs, product release and other quality system activities 
· Maintain ISO 13485 requirements 
· Ensure cGMP 
· Communicate customer requirements 
· Stay informed of the latest regulatory requirements
· Review and scrutinize compliance 
· Implement appropriate corrective and preventive actions 
· Present performance reports to C suite
· Continuously improve quality systems
· Participate in NPI
· Manage Staff

Required skill set:

1. BS required, Masters level preferred. 
2. Significant FDA quality control methods and quality assurance system experience 
3. 10+ years experience in the medical device, biotech or pharmaceutical industry (biotech/biologics strongly preferred)
4. Must have at least 5 years quality management in an FDA environment
5. Excellent knowledge of cGMP, ISO 13485 and quality system requirements 
6. Track record of managing and developing people


· Compensation: mid to hi 6 figures
· Location: Wareham / Cape Cod, MA
· Relocation: available

Contact:
Leslie Gabriele
Gabriele & Company 
Recruiters for Manufacturing and Materials

www.gabrieleandcompany.com
781-276-7999
leslie@gabrieleandcompany.com
http://www.linkedin.com/in/gabrieleandcompany

Posted 6-25-10

Links to job resources.

ASQ Career Center

Rhode Island Department of Labor and Training

Americas Job Bank

hotjobs.com
monster.com
engineerjobs.com
jobfind.com