The Quality Engineer is responsible for performing new and existing product and process validations, including new product First Article Inspection (FAI or PPAP), while supporting Paragon Medical Process and Design Excellence (Six Sigma) objectives. This position will also be responsible for the development of ongoing compliance with internal systems and procedures to meet certified requirements, as well as developing and implementing inspection/validation techniques necessary to verify products meet customer requirements at the earliest point in the production process. Additionally, this position will continuously facilitate proactive solutions to safeguard customer and business needs, as well as lead problem identification and resolution by anticipating outcomes and preparing the team to deal with potential eventualities.
DUTIES AND RESPONSIBILITIES:
- Leads the RMA/NC customer process and helps drive the CAPA process, including problem resolution and ensured closure.
- Mentors and may serve as supervisor for Quality Engineers and Quality Technicians within the facility.
- Creates and executes quality-related training materials for the division and Quality personnel.
- Designs and specifies required inspection equipment and holding apparatus to accommodate repeatable measurements.
- Leads or assists in leading multi-function continuous improvement activities.
- Represents company in meetings with customer to fully develop their requirements or as required in the manufacture of contracted products. Client point of contact.
- Leads and supports both internal and external audits of all corporate quality systems and demonstrates compliance through objective evidence.
- Ensures that the customer requirements have been identified and are adequately communicated, including but not limited to, "soft requirements" such as documentation, process limitations and quality requirements.
- Regularly completes gage R&R studies, training others in statistical techniques and process control/validations.
- Calibrate and control gages and measuring equipment used in production. Interpret and approve results from gage and process control studies.
- Leads, supports or participates in the Material Review Board (MRB) for internal non-conformances and customer returns.
- Designs inspection/validation steps to be taken by operations at the point of manufacture and integrate these steps into the manufacturing instructions.
- Responsible to create, implement and improve quality systems and procedures for meeting ISO, FDA and customer quality system requirements.
SKILLS:
- Knowledge of blueprint reading, GD&T, and machining processes.
- Written and verbal communication skills.
- Interpersonal skills.
- Ability to independently solve problems and make recommendations.
- Strong computer skills including excellent Word, Excel, PowerPoint, and Minitab skills.
- Organizational skills and attention to detail.
- Project management skills.
EXPERIENCE / EDUCATION:
- 4 Year / Bachelors Degree is preferred
- 7+ years of quality engineering or related role
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Physical demands: While performing the duties of this job, the employee is frequently required throughout the workday to sit, stand, walk, use hand/fingers to grasp/pinch/grip. Employee is occasionally required to climb (stairs); operate machinery and/or power tools. Must regularly be able to pull, push, lift and carry up to 20 pounds.
- Work environment: Primary work performed in an office environment. The noise level in the work environment is usually low. Exposed to a production environment with moderate to high levels of noise.
CompensationEmployee Type: Salaried
Currency: USD
Salary Minimum: 75,000
Salary Maximum: 110,000
Incentive: No
Disclaimer: Where a specific pay range is noted, it is a good faith estimate at the time of this posting. The actual salary offered will be based on experience, skills, qualifications, market / business considerations, and geographic location.
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