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Quality Engineer

Company Name:
Pinpoint-Pharma
Overview:
Provide engineering and technical support to the Quality Department. Coordinate and execute product management as appropriate to the Quality Department. Evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. Provide direct support to Quality Management/Quality Assurance personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.

Responsibilities:
Provide leadership in directing and promoting Quality Improvement processes.
Coordinate, and analyze databases associated with oversight of the Quality System and its reporting process.
Oversee the day to day management of Contract Manufacturing Organizations that supply finished goods to the company
Coordinate/Support the operation of Internal and Supplier Audit Systems. Provide leadership as required while conducting all such audits.
Support the operation of the Quality System process related to Corrective/Preventive actions and product non-conformance control including; capturing data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Review and approve internal operating procedures and specifications.
Oversee product and process validation activities as they relate to Quality Assurance projects.
Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related inspections as required.
Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices.
Provide assistance to the Manufacturing and R&D departments in the development and validation of new products and Manufacturing/Quality Control processes.
Assist with training to all company employees as required.

Qualifications:
BS in a Physical Science or Engineering, or equivalent experience required.
Minimum 2-4 years Quality Assurance and/or other regulated industry or similar experience required.
ASQ Certification as a Quality Engineer or equivalent desirable.
Strong technical and general problem-solving skills required.
Ability to work with company staff and communicate effectively throughout the organization is essential.
Preferred experience with statistical analysis of data.
Preferred experience with the sterilization of medical devices.
Preferred experience in performing internal and/or supplier audits.
Preferred experience in training of personnel.
Familiar with ISO 9000/ISO 13485 Quality System Standards, FDA Quality
System Regulations, GMPs, and/or other international medical device regulations.


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