Quality Engineer | Altoona, PA

approval, material receiving, internal audit process ad document control. Requires experience in ISO-9001/ISO 13485 or c GMP manufacturing environment plus demonstrated familiarity with standard quality concepts. 2.0 Supervisory Responsibilities: None. 3.0 Position Requirements: Note: Qualifications are based upon education, resume and/or work experience.

3.1 Minimum of 3 years of experience. 3.2 Possess a great attention to detail. 3.3 Must be able to work independently with minimal direction or oversight. 3.4 Must be able to maintain accurate and organized records. 3.5 Windows-based computer skills, familiarity with Microsoft Word and Excel. 3.6 Good organizational skills with ability

to manage multiple priorities. 4.0 Responsibilities include (but are not limited to): 4.1 Must be able to take a leadership role in Quality related decisions. 4.2 Proactively ensure batch records are reviewed prior to material release, ensuring paperwork is completed accurately, neatly and fully.

4.3 Performs through root cause analysis and establishes in-depth and robust corrective and preventative actions for both internal non-conformances and customer complaints. 4.4 backsses materials received against internal procedures and performs the necessary approval to release materials. 4.5 Ability to read unplanned deviations, change controls, validations and other technical documents/reports

to identify errors and/or potential non-compliance issues and to backss potential product/process risk.

4.6 Complete supplier approval paperwork for new incoming suppliers 4.7 Participate in internal audits and inspections including planning for audits, execution, and follow-up on audit findings. 4.8 Assists in the tracking and maintenance of document control activities. 4.9 Write, revise and review standard operating procedures (SOPs) and custom specifications. 4.10 Become thoroughly knowledgeable of the applicable SOPs and maintain that knowledge base. 4.11 Other duties as assigned 5.0 Education: 5.1 4 year college degree in quality/compliance related field or science-related field with 2-4 years related experience.

6.0 Physical Requirements: 6.1 Prolonged periods of sitting at a desk and working on a computer. 6.2 Must be able to lift up to 25 pounds at a time. 6.3 Must be able to access and navigate each department at the organization's facilities. 7.0 Working Conditions: 7.1 Conditions inside the office is generally quiet, periodically there may be mid-level noise from various equipment when traveling to other facilities.

Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.

Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.

and the customer Qualifications Required - Bachelor of Science degree in Mechanical Engineering or related four-year degree with equivalent experience Requires ability to use personal computer and various measuring devices Requires ability to read, understand, and interpret blue prints Requires ability to read, understand, and interpret quality measurement data Knowledge of various quality control procedures and practices including statistical process control Five years' experience in related quality management position Firsthand experience with ISO certification and maintenance Essential functions and responsibilities - Design all process control procedures by department to assure consistent

performance in production and delivery of products Train or assist in the training of all personnel in proper performance of duties to be consistent w/ established quality procedures Develop quality trend reporting data to enable individuals to suggest or implement continuous improvement opportunities Report on a monthly basis all quality trends and problems Develop and/or maintain programs to promote communication of quality standards & problem solving through employee training Monitor and survey the quality of incoming purchased materials and recommend quality improvements Audit current quality systems to backss their effectiveness and accuracy Maintain Quality Manual and related process documents

to conform with latest ISO9001:2015 standards Ability to lead a team to establish root cause of a quality issue Assist in performing audits and surveys of vendor's performance Assist as needed in process/engineering problem solving Maintain and/or establish ISO procedures Job Posted by Applicant Pro