Quality Specialist

Summary:

Review and monitor Company processes for conformity to quality guidelines.

Essential Duties and Responsibilities:

• Oversee quality assurance activities including returned goods, customer complaints, corrective actions, preventative actions, and internal audits.
• Review customer quality agreements and suggest change to internal procedures to ensure that customer requirements are embodied in the company’s procedures.
• Monitor conformation of practices to internal procedures through execution of internal audits and periodic review of key metrics and records.
• Participate in supplier monitoring meetings. Keep abreast of supplier qualification status to assure that necessary records are obtained prior to addition of supplier to approved list.  Review supplier desktop audits and provide feedback to purchasing and supplier on conformance of supplier system to Seabrook requirements.
• Work with purchasing to develop annual supplier audit plan. Participate in supplier audits. Assure that supplier’s respond to audit observations in a timely manner and review responses for completeness and adequacy.
• Assist with implementation of new quality initiatives. Assure that quality plans are documented.
• Keep abreast of regulatory procedures and changes and suggest changes to internal procedures to assure compliance.
• Assure that assigned activities are performed in accordance with Seabrook Quality Management System.

Education and Experience:

• College degree preferred. High School Diploma or GED required
• Minimum of 3 years related experience

Job Knowledge, Skills and Abilities:

• Familiar with FDA Quality System Regulations and ISO 13485 Standard.
• Strong computer skills.
• Strong interpersonal skills including, but not limited to, contributing to a team oriented environment, balancing team and individual responsibilities, and keeping emotions under control.

Physical Demands:

• Light physical exertion required
• Lifting/carrying Maximum lbs: 30
• Regularly required to stand, reach and move about the facility

EEO Disclaimer:

ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success.  All employees of ARCH Global 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