MSK Precision Products, Inc., a world-class medical device contract manufacturer located in South Florida, is looking for a highly talented Quality Manager to join our team.

We specialize in manufacturing superior high precision parts and assembly for the medical, telecommunication and aerospace industries. Complex medical and aerospace components are out specialty.

With a packaging and assembly department, MSK is capable of providing individual parts or complete finished assemblies for their customers.

Core competencies include Precision Swiss-Style Turning, CNC 5+ Axis Precision Cutter Grinding, CNC Milling, CNC Turning, Laser Marking, Laser Welding, Wire EDM, and Passivation.

Certifications are: AS9100D Certified - ISO 9001 Certified - ISO 13485 Certified

Quality Manager - Job Description, Skills and Qualifications

SUMMARY

Manages the Quality Department. Plans, coordinates, develops and directs quality processes designed to fulfill all customer requirements, both internally and externally. Works with the Management Team to achieve overall company results. Is the Management Representative for the company with authority and organizational freedom to resolve matters pertaining to Quality.

Essential Activities of the job include:

• Maintains the quality manual, documents (procedures, work instructions, forms, etc.) library and provides document control.
• Manages the internal audit process.
• Manage quality inspectors: FAIR's, final, first piece, in-process, SPC and outside work.
• Manage gage control and calibration system including all other quality measuring equipment.
• Manage CMM machines and programs.
• Manage subcontractor approvals and performance.
• Coordinate employee training and qualifications.
• Coordinate the resolution of customer issues.
• Offers technical support with investigations of customer complaints and corrective actions.
• Resolve matters pertaining to quality.
• Perform any other task requested by management.
• Is aware of and understands ALL operating procedures and work instructions and "MSK's Quality Policy."

As Management Representative has the Independence, Responsibility and Authority to:

• Development of an AS9100, ISO9001 and ISO13485 compliant quality system, achievement of Registrations and ongoing maintenance of the quality system.
• Ensure FDA establishment registration is completed annually.
• Report on the performance of the Quality System to the Management staff and to provide a basis for improvement in the system and ensure the quality system is and remains effective.
• Act as liaison with external parties, including but not limited to, registrars, auditors, customers and suppliers on matters related to the quality system.
• Stop work and delivery of non conforming items.
• Initiate corrective actions and verify implementation of effective solutions for all customer complaints.
• Direct all activities of Quality Department resources in supporting the quality system requirements.
• Identify cross functional quality problems, initiate actions, make recommendations and verify implementation of effective solutions with all Management personnel up to and including the President.
• Identify resource issues (personnel, capital, project, etc.), initiate actions, make recommendations and verify implementation of effective solutions with all Management personnel up to and including the President.
• Initiate changes to the scope, frequency and resources performing internal audits.
• Be the focal point for any employee to report issues related to the quality system and for coordinating corrective action for changes and improvements.

Job Requirements:

• BS degree in Engineering a plus.
• 3 to 5 + years' experience with medical device or similar manufacturing.
• Must have thorough knowledge and understanding of AS9100, ISO 9001, ISO 13485, FDA and standard medical device industry guidelines.
• Experience hosting external audits and responding to Regulatory Authorities.
• Experience in CNC manufacturing a plus.
• Experience in common PC programs, Excel, MRP's, Word, etc...
• Working knowledge of standard metrology equipment essential (Mics, calipers, bore gage, etc...)
• CMM experience using Zeiss Calypso software, CMM programming a plus.
• Strong mechanical aptitude and exceptional problem-solving skills a must.
• Experience performing Quality Audits (both Internal and Vendor).

Benefits:

• Vacation & Holiday
• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Referral program
• Short-Term and Long-Term Disability
• Vision insurance
• Voluntary benefits, including Accident, Critical Illness with Cancer, Whole and Term Life Insurance

Please submit a resume with past experience listed for consideration. We appreciate your interest in our company!

• Drug free workplace / EOE, including disability/vets

Employment is contingent upon successfully passing a background check and drug screen.