Praxis is currently hiring for two positions:
- Quality Assurance Technician
- Quality Engineer
Quality Assurance Technician
The Quality Assurance Technician is responsible for activities including inspection, product receipt and quality control required to release product for medical device, aerospace and consumer components, complying with procedures, regulations and maintaining adequate records.
- Perform qualification activities including drafting test procedures, protocols and reports and performing tests according to written protocols and procedures.
- Assist Quality Engineer in addressing any deviations identified in qualification activities.
- Perform activities relating to drafting new procedures, engineering specifications and record sheets.
- Assist Quality Engineer in rectifying any discrepancies identified during incoming, in-process and final inspection activities.
- Comply with company procedures and policies, industry standards, and applicable regulations.
- Support project management objectives by meeting timeline commitments and balancing multiple priorities.
- Participate in conducting audits to ensure compliance.
- Enforce Current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs) during all activities.
- A minimum 1 to 3 years related experience and/or training in Quality Assurance or Quality Systems function in the medical device or similar regulated industry.
- Microsoft Office applications with Excel experience.
- Understanding basic math rules.
- Quality System Regulation experience is preferred.
- Knowledge of ISO 9001, ISO 13485, or AS9100 is preferred.
- Experience with electronic QMS is preferred.
- Lean Manufacturing and Six Sigma training a plus
- Results oriented
- Demonstrated ability to work independently
- Attention to detail, positive attitude, motivated, strong organizational skills, team player
- Strong communication skills
The Quality Engineer contributes to the consistent quality of product by maintaining, analyzing and improving Praxis Technology’s Quality Management System to meet customer’s expectations, company objectives and applicable regulations and standards.
- Plan, coordinate and direct quality programs, initiatives and activities to ensure the quality and compliance of Praxis products.
- Develop and implement quality controls, process sampling, and inspection procedures.
- Manage manufacturing validation IQ/OQ/PQ, approval activities, change control and documentation approvals.
- Support new product qualification and new process qualification,
- Support improvement programs (LEAN, Six Sigma experience preferred).
- Manage the review of product for release of product to shipping.
- Maintain and improve the gage calibration system and activities.
- Direct risk management activities, FMEAs and ensure compliance to standards and regulations.
- Manage the failure investigation of product complaints, NCR’s and CAPA activities.
- Manage the receipt and acceptance activities for purchased materials.
- Support the approval, maintenance and improvement of suppliers.
- Support preparation for and conducting of regulatory agency inspections and audits.
- Support improvement and maintenance of an effective employee training program.
- Support the use and maintenance of the MasterControl System
- Support the maintenance and integrity of the Quality Management System and the GMP activities.
- BS degree in engineering or equivalent.
- 3+ years of experience in a quality role in support of the medical device or aerospace industry.
- Working knowledge of quality improvement tools and techniques.
- Proficiency with MS Office software. MS Project a plus.
- Knowledge of risk management processes, and FMEA analysis.
- Basic statistical analysis and data analysis competence. Minitab a plus.
- Excellent verbal and written communication skills; demonstrated ability to write technical documents.
- Effective problem solving skills and familiarity with root cause analysis tools.
- Excellent attention to details, organizational skills with demonstrated ability to prioritize workload and work on multiple priorities at one time.
- Ability to meet deadlines while maintaining a high degree of accuracy.
- Ability to effectively work independently and collaboratively as part of a team.
- Knowledge of FDA Quality System requirements, ISO 13485, AS 9100, ITAR and FFL.
- Knowledge of GMP (Good Manufacturing Practices).
- Education and experience applying lean manufacturing principles, and / or six sigma is preferred.
- Auditing experience is preferred.
- Knowledge of MasterControl or an electronic QMS is a plus.
- ASQ certification is a plus.
If you are looking for the opportunity to become part of a company that offers highly competitive compensation, benefits and advancement in a culture that inspires teamwork and commitment, submit your resume to firstname.lastname@example.org.