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Quality Assurance Manager/Inspector Small high tech manufacturer of precision equipment for biotech applications in the Hartford, CT area is looking for a hands on Quality Manager who will do quality engineering, audits, as well as do some inspection work directly. Will manage a staff of one. Should be comfortable in wearing lots of hats. One shift operation. 5 day work week. $65-$90k. Immediate need.
Summary: Manages Quality System to meet requirements of ISO 9001/13485 standards. Conducts inspections and documents results.
Duties/Responsibilities:
Ensure that the company is in compliance with national and international regulatory and quality system regulations and that the company maintains full compliance with these regulations and with all corporate quality policies and procedures.
Act as ISO Management Representative.
Prepare and present Quality Management Review Reports.
Facilitate ISO Compliance Audits and inspections/visits and prepare facility for the same.
Maintain internal auditing program per ISO requirements. Manage Document Control Process. Facilitate CAPA process.
Participate as an active member on product development teams and in Design Control reviews when necessary. Act as quality liaison with regulatory agencies as needed. Maintains and enforces the Company's Quality Manual and all related documentation. Manage Material Review Board (MRB) activities. Tracking and trending of Supplier Quality. Facilitate Gage Calibration. Conduct and document inspections: Inspect detailed and precision machined parts (various materials).
Perform inspection utilizing standard gages – including optical comparator, various hand-held gages; portable CMM experience a plus.
Inspect Sub-Assemblies and Final Assemblies (including: electronic / robotic assembly inspection).
Inspect consumable products (experience with scientific labware a plus).
Follow / interpret Engineering Drawings and specifications.
Perform First-Article / In-Process Inspection as needed (may include source inspection.
Review / audit supplier generated quality records.
Document and communicate inspection results in a clear and concise manner.
Skills/Knowledge/Educational Requirements:
Bachelors Degree in Science, Engineering, Quality or related field.
5 – 7 years experience in a Quality role in a manufacturing environment. Knowledge / experience with ISO 9001 / 13485.
Knowledge and experience with process validation, risk analysis.
Proven track record of experience in Quality System Regulatory Compliance.
Significant experience with Micrometers, Calipers, Height gages, pin gages; utilizing general layout inspection techniques. MUST be proficient in reading complex technical drawings (component level and assembly level). Mechanically inclined – ability to fixture components & assemblies to enable accurate inspection. Knowledge / experience facilitating Gage Calibration. ASQ CQE and/or CQM a plus. GD&T experience a plus. Supplier Quality Engineering experience a plus. Demonstrated leadership skills and a team player; objective, level-headed, honest. Demonstrated decision-making skills. Strong written and oral communication skills. Strong computer skills (Word, Excel, Powerpoint) Tim Flanagan CPC
Senior Partner
Hobson Associates
1781 Highland Ave.
Cheshire, CT 06410
phone: 203-272-0227 ext. 119
fax:203-272-1237
email:
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web site: www.hobsonassoc.com
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