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LEAD QA ASSOCIATE JOB LOCATION: MILFORD, MA RESPONSIBILITIES: · QA project representative on Manufacturing campaigns. · Play a key role in the cGMP compliance activities at the Milford site and continuously work with other departments to maintain and monitor compliance with cGMPs. · Act as lead auditor during vendor/internal quality audits to ensure that cGMP compliance is at the required standard for API manufacture · Support validation activities by providing input on the review and approval of validation protocols/reports and ensure compliance with FDA validation guidelines and Avecia’s validation master plan. · Reviewing quality records · Responsible for writing/revising Quality Assurance procedures to strengthen compliance with cGMPs. Reviewing and approving deviations and gathering/issuing quality metric reports to executive management. · Manage the CAPA program, including chairing the Material Review Board and conducting QA investigations. · Conduct customer complaint investigations, and follow up with customers on all technical complaints until closure/resolution is reached. · Provide assistance during cGMP compliance inspections of the Milford facility by retrieving documentation requested during inspections. QUALIFICATIONS: · BS/BA in science or equivalent experience with 5+ years experience in either Production or QA. · Must have a strong knowledge of the cGMP regulation and technical knowledge of the subject and the potential issues involved. This is achieved through a combination of experience in Quality Systems coupled with education and training in Quality Systems, cGMP, Quality audits, documentation, change control, corrective and preventative action, validation, calibration, review of quality records, quality metrics, failure investigations and manufacturing and laboratory controls. CONTACT: Apply directly through our website AveciaCareers.com Equal Opportunity Employer |
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Quality Manager
Location:
Taunton / Wareham area…local candidates only www.gabrieleandcompany.com
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Quality Engineer
LOCATION: Cranston, Rhode Island
RESPONSIBILITIES:
QUALIFICATIONS:
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. |
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Quality
Specialist |
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Quality Engineer Lauren
Gablinske, Technical Recruiter at Summit-Technical lgablinske@summit-technical.com or 401-738 9097, Ext 1044 |
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Quality Control Supervisor
MicroGroup is a rapidly growing contract manufacturer serving the medical device industry with facilities in Medway, Massachusetts and Bethel, Minnesota.
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 |
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Validation Coordinator
Info
and how to apply online:
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Director
of Quality
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: Contact: www.gabrieleandcompany.com
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Links to job resources. |