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Quality Engineer, Manufacturing Jobs
Company | Hound Labs, Inc. |
Address | Fremont, CA, United States |
Employment type | CONTRACTOR |
Salary | |
Category | Technology, Information and Internet |
Expires | 2023-09-09 |
Posted at | 9 months ago |
About Hound Labs, Inc.
- Provide quality engineering support for quality, manufacturing, design & development, documentation, and other product related disciplines
- Assist with design transfer to ensure all requirements are effectively implemented within Operations
- Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem-solving techniques
- Ensuring the promotion and awareness of customer requirements throughout the organization
- Perform other related duties or special assignments as specified by manager
- Assure all areas within Operations (i.e. manufacturing, inspection, incoming, inventory, etc.) are compliant and are maintained in an inspection-ready status
- Perform and document investigations related to processes and quality systems, as needed
- Provide quality training to site staff and new hires in the use of the quality system and associated requirements
- Assists with the development of manufacturing procedures, inspection procedures, and implementation of the manufacturing process
- Responsible for ensuring complaints are appropriately logged, evaluated, investigated, and documented
- Manage risk documentation to ensure proper documentation and mitigation of risks as it relates to processes
- Gather quality metrics and analyze for trending and inclusion into Management Review and the CAPA process, as necessary
- Responsible for evaluating suppliers in accordance with SOPs for inclusion onto the Approved Supplier List (ASL), ensuring all documentation and records are complete and meet requirements
- Responsible for equipment control, including preventive maintenance, calibration, and qualification activities
- Responsible for ensuring nonconformances are processed in accordance with SOPs, including investigation, disposition, segregation, and that appropriate records are completed
- Perform QA/QC inspections, as necessary
- Review and approve process, test method, and equipment verification and validation protocols and reports, as needed
- Maintain a thorough knowledge of current QSR and ISO requirements as they apply to the medical device industry
- Assist with CAPA initiation, investigation, and verification of effectiveness, as needed
- Assist manufacturing personnel to develop, establish and maintain work environment and infrastructure requirements
- Interest in Hound Labs’ mission and desire to affect change
- Self-starter mentality and an understanding of when to elevate key details for approval
- Intellectual curiosity, creativity, and eagerness to learn and teach
- Ability to communicate efficiently with multiple people both internally and externally
- Comfortable navigating ambiguity
- Poise, resourcefulness, aptitude for problem solving, and the willingness to suggest alternative approaches based on experience and research
- Ability to effectively juggle many priorities while remaining flexible to changing deadlines
- Confidence to accept feedback
- Great work ethic, ability to adapt quickly to changing priorities and shifting workloads, and an eye for making decisions that ensure the success of key internal and external stakeholders
- 5+ years of Quality Engineering experience within a medical device manufacturing environment required
- Experience with Medical Devices quality management systems standards (e.g. ISO 13485)
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- ASQ certification a plus
- Bachelor’s degree in engineering or equivalent discipline or equivalent work experience
- Must be comfortable in a fast-paced small company environment with changing priorities
- Days and hours of work may be variable depending on business need
- Occasional evening work may be required as job responsibilities demand
- Full-time position
- Travel to vendors, conferences, company meetings, and other events may be required
- Indoor position that requires sitting at computer for an extended period
- Exposure to moderate to loud noise and light as typical in a manufacturing environment
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