Position Summary:

This position will support new project and R&D activity, Production, Manufacturing Engineering, and Purchasing with all quality directions, investigations, root cause analysis, and corrective actions. This position will support our Quality program as directed. The perfect candidate must have optical, mechanical and electro/mechanical skill sets.

Essential Duties and Responsibilities

· Provide leadership in creating a quality focus within the company through regular communications with peers, managers and key suppliers documenting the impact of quality and reliability on business performance.

· Manage, lead and perform periodic audits of the Convergent Photonics Quality Management System (QMS). This includes procedures for product design and development, assembly, customer support, and other key business processes.

· Along with division and management, identify opportunities for continuous improvement, formulating corrective, preventive and improvement actions, and working to implement those actions in order to improve results relative internal and external quality metrics, initiatives and regulatory compliance.

· Document and lead in implementing methods for identifying and prioritizing opportunities to improve the quality and reliability of current products based on input from various sources including manufacturing processes, internal and external customers and suppliers. Document methods for measuring and reporting on the effectiveness of continuous improvement initiatives. Participate in value stream mapping activities.

· Develop and implement data capture methods/systems to monitor, communicate and report on progress in achieving the divisional and quality goals and strategic thrusts.

· Be the ISO 9001 contact for Convergent Photonics with the certifying registrar (presently TUV SUD.) This includes being the primary contact for the registrar’s certification surveillance audits. Maintains compliance to all applicable regulations and requirements (CLIA, CAP, NYS DOH, FDA, ISO, etc.). Familiar with laser safety requirement, ISO 13485 and IEC60825 or/and IEC 60601-2-22 is an important plus.

· Supports all R&D and manufacturing activities including process validations, policies and procedure review, batch record review, DMR review, DHR review, nonconformances, and CAPAs. Conducts gap analyses and best practice reviews to sustain and continually improve the Quality Management System.

· Manage all audit and incoming inspection requirements and/or supplier inspections on site.

· Perform quarter/annual internal audit/inspection of final product and assemblies; handle all material purges

· Working with Purchasing to administer a supplier certification process and vendor rating system.

· Support Production on all quality issues, including problem resolution on manufacturing floor, to ensure the timely delivery of goods, materials, supplies as well as product to the company's customers.

· Maintain and track the status of quality activities related to suppliers; supplier qualification, first article inspection, nonconforming material reports, corrective actions, and source inspections.

· Participate in all the ECO, product development Management review meeting.

Qualification Requirements:

· College degree in Engineering, Mathematics or Science in equivalent.

· Demonstrated strong problem solving skills, root cause analysis and corrective action.

· Demonstrated verbal and written communication skills. Self-motivated and ability to work with little supervision.

· Working knowledge of statistics and widely used tools and techniques for quality planning and quality improvement (e.g., PDCA.).

· MS Office proficient, ERP system background preferred.

· Three + years’ experience in a progressive quality environment

· ASQC member a plus.

Competencies:

• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes documentation tasks correctly and on time. Follows instructions and responds to management direction.
• Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
• Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Job Type: Full-time

Pay: $75,000.00 - $87,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Chicopee, MA 01020: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 9001: 3 years (Required)
• ISO 13485: 1 year (Preferred)

Work Location: In person

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