Quality Engineer Manager Ii Jobs

This is a virtual/remote position, working from home.

Conduct audits in a professional, ethical, and objective manner using and interpreting applicable standards/requirements.

Maintain in-depth working knowledge of procedural changes, audit techniques, and plan automated systems, subsystems, and reference materials for assigned audit functions.

Demonstrated skills in Microsoft Office Suite: Outlook, Access, Word, Excel, and PowerPoint.

Resolve conflict directly and respectfully, engaging in challenging and important conversations to resolve audit findings.

Identify trends and the root cause of errors and recommend improved procedures/guidelines to Operations proactively.

Strong knowledge of test data management to reuse automated test data provisioning capabilities

Working experience with GitHub, Jenkins for the source code management

Effectively engineers and leverages tools and Engineering practices (DevOps tools and processes, source code management, Service Virtualization, monitoring tools, etc.)

Ensures respective programs/ policies/practices are well managed, meets business needs, complies with internal and external requirements, and aligns with business priorities

Actively manages relationships within and across various business lines, corporate and/or control functions and ensures alignment with enterprise and/or regulatory requirements

Maintains a culture of risk management and control, supported by effective processes in alignment with risk appetite

Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) and design change control requirements are met.

Previous experience working with Quality Management System (ISO 13485 and 21 CFR 820) is preferred.

Strong organizational and project management skills with an attention to detail and accuracy

Perform design control and risk management activities according to RapidAI’s Quality System.

Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.

Medical Benefits – We offer a range of policies through TriNet

Provides input to management on quality and compliance. Ensures corrective actions implemented are effective.

A minimum of two (2) years of working knowledge and experience in a cGMP/highly regulated manufacturing environment.

Ability to apply risk management philosophy to business processes, decisions and data.

Must have proven skills to perform tasks accurately.

Must have skills to perform tasks without continuous supervision but seeking input as needed.

Strong troubleshooting skills to assist with defining problems, collection of data, establishment of facts and drawing valid conclusions.

Provide support for QMS (Quality Management System)

Oversee Document Control as well as product life cycle management.

$80,000 - $110,000 per year (based on experience)

Experience with CAPAs, Supplier Quality, Internal/External Audits, NPRs, Document Control, eQMS.

Assistance with audits - both internal and external

Collaborate with other departments in order to address quality issues and facilitate CAPA procedures.

Good documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills

Experience withmedical device compliant investigations (CAPA's, NCR's, Root-Cause Analysis)

Experience inmedical devices(cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.

Experience in complaint investigations,root cause analysis, and the associated risk assessments preferred.

Previous experience working with lab/industrial equipment required

Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

Strong knowledge of test and defect management tools like Jira/Azure DevOps required.

EXPERIENCE, SKILL And ABILITY REQUIREMENTS

Strong knowledge and experience with testing methodologies required.

Capture and generate software quality metrics and status reports for assigned team to management

Utilize defect management tool to log and track all defects identified during testing

4 years of experience in software quality testing required.

Leads cross-functional teams in the execution of risk management activities.

2+ years of related experience (regulatory/audit experience).

External Auditor Certification (e.g. ASQ Certified) desired.

Experience in the application of cGMPs.

Able to demonstrate excellent problem solving and critical thinking skills and understanding of complex manufacturing processes.

Experience in utilization of electronic systems such as TrackWise.

Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.

Spine & Biologics, offers procedural solutions for spine surgery, and bone grafting solutions for spinal fusion. 

US and International travel requirement: Less than 10%

China Cranial, Spinal, Orthopedics & Technologies, provides solutions in spine surgery, neurosurgery, surgical synergies, biologics, and orthopedics.

Define and maintain statistical thresholds for complaint monitoring. Execute post market trending process.

Collaborate with cross-site Post Market Quality, Regulatory Affairs, and Engineering to support and author pre- and post-market product risk assessments.

Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.

Spine & Biologics, offers procedural solutions for spine surgery, and bone grafting solutions for spinal fusion.

US and International travel requirement: Less than 10%

China Cranial, Spinal, Orthopedics & Technologies, provides solutions in spine surgery, neurosurgery, surgical synergies, biologics, and orthopedics.

Define and maintain statistical thresholds for complaint monitoring. Execute post market trending process.

Collaborate with cross-site Post Market Quality, Regulatory Affairs, and Engineering to support and author pre- and post-market product risk assessments.

Collect and provide reports and data to management; and assist with completing surveys, audits and certification.

Manage special handling requirements for hazardous material as needed.

High School diploma or equivalent combination of education and experience required. Associates degree or equivalent preferred.

Has developed specialized skills through job-related training and considerable on-the-job experience.

Perform inspections, analysis and/or testing to specifications, requirements, and industry standards, using specialized instruments as needed.

Complete related documentation, paperwork and data entry.

Must have 2 years of experience in Quality Engineering

Strong communication, collaboration, and problem-solving skills are required.

Both, FDA, and ISO regulations knowledge is required.

Strong root cause analysis skills are required.

Operations supplier quality experience is preferred.

Experience in the medical device and/or pharmaceutical industry is preferred.

Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.

Lead and manage complaint investigations.

Coordinate and lead preparation of Quality Plans including inspection, test and gauge requirements for new product introductions.

3+ years’ experience in medical device or other regulated manufacturing industry Bachelor’s Degree in related field.

Strong communication skills and ability to align with key stakeholders.

Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

Practical knowledge of project management

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Contribute to risk management activities including PFMEA generation.

Experience of utility qualification, equipment qualification, process validation, packaging validation, distribution studies, aging studies.

Specialized knowledge level, seasoned professional with complete and in-depth conceptual and practical knowledge in one or many areas of Quality Validation

Applies knowledge of job discipline's best practices to internal processes

Supports development, implementation and management of quality training and education programs

Oversees the design and implementation of a global Quality Management System

Establishes a common set of quality analytics to proactively monitor quality management systems including audits, documentation control, training

Oversees and manages compliance auditing and tracking, including the shared audit management process

Knowledgeable in current regulatory and/or quality certification(s) such as CQA, CBA, CQM, RAC, etc.

Demonstrated knowledge in quality processes and regulatory requirements such as ISO 9001, ISO 13485

Strong knowledge of test and defect management tools like Jira/Azure DevOps required.

EXPERIENCE, SKILL and ABILITY REQUIREMENTS:

Strong knowledge and experience with testing methodologies required.

Capture and generate software quality metrics and status reports for assigned team to management

Utilize defect management tool to log and track all defects identified during testing

EDUCATIONAL, CERTIFICATE and LICENSE REQUIREMENTS:

Leads cross-functional teams in the execution of risk management activities.

2+ years of related experience (regulatory/audit experience).

External Auditor Certification (e.g. ASQ Certified) desired.

Experience in the application of cGMPs.

Able to demonstrate excellent problem solving and critical thinking skills and understanding of complex manufacturing processes.

Experience in utilization of electronic systems such as TrackWise.

B.S. in engineering or an alternative bachelor’s degree program with certification as a quality engineer (e.g. CQE).

Minimum 1 year of relevant work experience.

Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred

Formulates procedures, specifications, and standards for Zimmer products and processes.

Develops and implements corrective/preventative action plans.

Collects and analyzes data for gauge and product evaluation.