Director of quality Jobs in Philadelphia, PA

MUST HAVE DIRECT PRIME QUALITY EXPIERENCE FOR CONSIDERATION FOR THIS ROLE!

Job Details

Description

Summary

The Director of Quality Assurance is responsible for developing and directing robust quality processes and procedures to ensure the products manufactured meet customer requirements and specifications, including FDA, and AS compliance, as applicable. This position will develop and grow a capable team of quality assurance staff to achieve company goals and objectives.

Primary Duties

• Lead as the management representative for FDA 21 CFR 820 and AS certifications
• Responsible for creation, implementation and maintenance of the Quality System processes, in compliance FDA 21 CFR, Part 820, Quality System Regulation

o Systems include Corrective and Preventive Action, Non-conformance and Material Review Board, Validation and Qualification, Management Review, Document and Record Control, Risk Management Activities, Training and Resource Management, Supplier Management, Internal Audit System, Calibration, Inspection and Inspection Planning, RMA and resolve of customer complaints.

Required Education and Experience

Necessary Skills, Abilities and Knowledge

Additional Notes

ALIGN Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ALIGN Precision are employed on an at-will basis.

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)