Provide significant support for the management and modification of the current Quality System to maintain compliance with latest ISO 9001:2008 and AS 9100 systems requirements.
Provide significant support, preparation and maintenance preparedness of the organization for ISO 9001 / AS 9100 audits.
Coordinate, prepare for and oversee customer and external audits.
Review data documentation before presentation to Source Inspector.
Coordinate, prepare and record all internal audits and findings.
Play an active role in addressing non-conformities from previous internal and external audits; issue RCAs, preventive and corrective actions, and follow up on efficacy of actions as required.
Document Controls & Output
Ensure that documentation and design controls are appropriate.
May be required to author, revise and maintain Astro Pak Cleanroom procedures.
Oversee and/or issue and approve routers and/or work instructions for hardware processing.
Help to revise and maintain technical specification library.
Ensure technical compliance with all specifications.
Oversee established calibration and testing program.
Training & Accountability
Direct and supervise the selection, training, development, appraisal and work assignments of quality personnel at the primary location.
Partner with HR Department to develop and implement proper training and organizational processes for Cleanroom. Ensure ongoing training and organizational processes drive desired practices, behaviors and company culture.
Provide leadership to others through example and sharing of knowledge/skill.
Support the evaluation and performance of quality personnel annually; provide coaching for performance improvement and growth.
Liaison with Management
May be asked to serve as management level point of contact for all customer quality issues.
May be asked to assist the management team and provide QA/QC support as necessary.
Participate in proactive team efforts to achieve departmental and company goals.
Comply with all safety policies, practices and procedures.Report all unsafe activities to supervisor and/or HR.
Education: Bachelor's degree (B. A. or B.S.) from four-year college or university; or three to five years related experience and/or training; or equivalent combination of education and experience.
Related Experience: At least 3 years of work experience in Quality Assurance, should be combined with a demonstrated track-record of accomplishments as a Quality Assurance Manager, and with satisfying customers in technology-driven, developing companies. Experience with aerospace quality management strongly preferred. Experience with ISO quality systems mandatory; experience with AS 9100 rev C strongly preferred.
Essential Skills: Strong oral and written communication skills. Strong interpersonal skills, and superior organizational abilities. Ability to interact at all levels of company and with people of various backgrounds and experience. Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment. Excellent proficiency in PC-based computing (Word, Excel, PowerPoint, and cGMP documentation) is essential.
Other Cognitive Skills:
Language Skills: Ability to read, analyze, and interpret complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to lead effective meetings and deliver persuasive presentations on complex topics to employees, coworkers, and top management.
Mathematical Skills: Ability to apply statistical analysis techniques such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
10% exposure to typical cleanroom environment (noise, odors, cleaning chemicals).
Team and customer oriented
Proactive and handles stress well
Effective listener and communicator
Additional Salary Information: Salary will be commensurate with experience. Astro Pak Corporation offers a competitive benefits package including health and dental insurance, 401K retirement program, company paid holidays.
For almost 60 years, Astro Pak has been the leader in providing Passivation, Precision Cleaning and High-Purity Chemical Cleaning services for a wide variety of “cleanliness sensitive” critical systems and components. We have been perfecting our cleaning chemistries and processes, deploying crews and equipment to go on site to customer facilities, as well as process components, hardware and assemb...lies at our state of the art Cleanrooms and Shop locations. Many of our customers have external agencies that drive their cleaning requirements, such as the FDA, NASA and others. We service a myriad of industries including Biopharmaceutical, Food & Beverage, Aerospace, Laser, Water Wastewater, and several Industrial markets.