- Ensure machined parts, assembled products and manufacturing processes meet documented requirements to support the business objectives.
- Perform first-article and in-process inspections for the Machine Shop and Assembly areas.
- Inspect dimensions, and assemblies to engineering drawings. Ensure proper assembly of all sub-assemblies and finished devices.
- Inspect the work of machinists and assemblers during the production process, to ensure requirements are being met.
- Verify cleanliness of product in accordance with procedures and/or part drawings provided.
- Verify all work orders and associated documentation is present, complete, and accurate.
- Process completed work orders in accordance with company processes.
- Initiate nonconformances into the QMS, thoroughly document the specifics of the issue. Assist with investigations as required.
- Document inspections to comply with Regulatory requirements and Percussionaire internal procedures.
- Provide feedback from internal customers for individual, department, process, and company improvement.
- Familiarity with and ability to conduct gauge studies and test validations.
- Manage calibration program and ensure all inspection tooling used in production is in good standing and calibrated.
- Complete assigned tasks for Engineering Change Notices (ECNs) as they impact inspections and calibration equipment.
- Knowledge of Quality Management System (QMS).
- Be proficient with applicable standards and regulations as outlined in the QMS.
- Demonstrate professional written and oral communications.
- Display ethics aligned with the company's mission.
- Adhere to the company policies and employee handbook.
- Verify documentation completed by Manufacturing, Calibration, and Machine Shop personnel for accuracy and GDP requirements.
- Inspect and release finished product.
- Review, revise, and approve inspection plans.
- Evaluate component complaints.
- Understand device defects may occur from improper performance of specific job function to prevent releasing devices that will not achieve their intended purpose.
- Utilize IT resources for efficient execution of duties (QMS).
- Abide by all safety and security rules set forth by the company and regulatory agencies.
- Performs all other duties and responsibilities as assigned.
Requirements
- High School diploma or equivalent required.
- One (1) year of experience performing quality inspections required.
Competencies:
- Quality experience in a medical device manufacturing environment desirable.
- Experience using inspection equipment such as gauges and calipers required.
- Ability to read, comprehend and interpret engineering drawings.
- Mechanical ability
- Basic mathematical skills
- Basic reading skills.
- Detail orientation required.
- High accuracy skills required.
- Good eye to hand coordination.
- Ability to read, write, and comprehend the English language.
- Good teamwork/interpersonal skills to work with co-workers and other departments.
- Detail oriented.
- Personal accountability.
- Dependability.
- Ability to follow instructions with little or no supervision.
- Strong communication skills.
- Multi-tasking with ability to prioritize.
- Ability to focus.
Benefits
- Meaningful work in a rapidly growing company with opportunity for advancement
- Directly influence the quality of products and make a difference for patients worldwide
- Opportunities for professional and personal growth
Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth. Sentec focuses on delivering impactful healthcare products and improving patient care.