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26 days old

Quality Engineer

Kelly Services
Gaithersburg, MD 20898
**Quality Engineer**


Gaithersburg, MD


Direct Hire/Salaried


Kelly Science & Clinical is supporting our global client focused in the development and manufacturing of a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We are hiring a Quality Engineer and Subject Matter Expert to act as the right-hand person to the Quality Manager and execute critical functions within the quality department.


The Quality Engineer is responsible for reviewing, analyzing, and improving quality management systems, production processes, and overall product use and service experiences for our customers by identifying, evaluating, communicating, and controlling explicit and implicit requirements. Reporting to site lead for Quality Assurance, this role requires sound quality engineering practices for problem solving, risk assessment, and overall change control to achieve the goal of consistent, high quality products through efficient, controlled processes. Key activities for this role are centered around sustaining production support as well as design control activities for new product development. Specific tasks include oversight of verification and validation activities, data analysis and trending, root cause investigation and corrective action, and change management as well as review and release of batch and raw material records.


**Key Responsibilities**


+ Manage site validation activities encompassing equipment qualification, and software and process validations. Maintain Validation Master Plans. Provide support during product and process validations by guiding the team through IQ, OQ, and PQ stages of the validation process. Review, approve, author, and execute validation protocols and reports.

+ Manage site change order process to assess and appropriately document risk including impact to internal and customer-related processes. Coordinate with functional teams across multiple sites to ensure timely completion of change activities.

+ Work with Manufacturing Operations, QC, and Technical Support to evaluate production processes and monitor product quality performance. Collaboratively solve manufacturing and quality issues.

+ Investigate quality issues and trends from customer complaints, NCMRs, CAPAs, etc. to identify actions required.

+ Participate in and lead teams during the investigation of root cause, quality problems, and complaints using statistical techniques (DOE, ANOVA, Regression, Analysis, etc.). Implement appropriate and efficient corrective actions to avoid problems and/or prevent recurrence.

+ Review and approve Document Change Requests (DCRs) related to materials, production processes, test methods, and quality plans as required.

+ Oversee risk management documentation with deliverables including risk plans, risk assessments (design and process FMEAs), and risk reports. Review risk control actions for completeness, feasibility and adequacy. Track mitigation efforts to reduce medium and high risks to acceptable levels.

+ Identify improvements to reduce scrap, rework, complaints, and other sources of Cost of Poor Quality (COPQ) in line with quality and cost reduction initiatives.

+ Initiate SOP changes to streamline, standardize, and improve quality system processes.

+ Support large-scale projects such as electronic systems implementation and integration.

+ Support ongoing product release activities such as review of raw material receipts, batch records, QC results, and environmental monitoring records. Assess excursions with appropriate deviations and/or risk evaluations.

+ Work with Facilities to evaluate equipment performance requirements and management of calibration, preventive maintenance, and unscheduled repair activities. Review controlled space monitoring reports and evaluate Out of Tolerance (OOT) and repair events for impact to product quality.

+ Support product stability studies through careful review of challenge conditions and requirements.

+ Perform internal and supplier audits, issue audit reports, and follow up to close out actions which address the findings.

+ Provide training and support for quality concepts and tools.


**Knowledge, Experience and Technical Skills**


+ Ability to interpret FDA QSR regulations as well as ISO 13485 and ISO 14971

+ Comprehensive validation experience including ability to guide prospective, concurrent, and retrospective studies

+ Knowledge of statistical methodologies, quality control and manufacturing operations

+ Ability to strategically evaluate and implement practical, timely resolution of non-conformances, deviations, customer complaints, and CAPAs

+ Intermediate to advanced computer skills with word-processing systems, spreadsheets, databases, ERP systems, and electronic quality management system software

+ Strong interpersonal, organizational, verbal and written communication skills

+ Demonstrates curiosity, adaptability and commitment; works best in a team environment and actively seeks to foster relationships

+ Focused on problem solving including problem definition, risk evaluation, and risk-based resolution

+ Ability to ask probing questions to understand unstated expectations and underlying issues, understand competing priorities, and facilitate discussions to gain consensus through the problem-solving process

+ Oriented for continuous improvement with desire to always balance the level of control and flexibility in systems based on risk

+ Strong analytical and examination capabilities for complex projects; ability to develop process maps, organize data, evaluate options, document plans, and communicate progress.

+ Strong attention to detail

+ Performance driven with ability to work positively and collaboratively with cross-functional teams

+ Ability to manage multiple tasks and meet timelines with minimal supervision


**Education and/or Experience**


+ Bachelors Degree in a scientific discipline with experience in quality engineering

+ 5 + years experience working in a cGMP or ISO 13485 environment

+ Experience with Lean and/or Six Sigma concepts highly desired


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-20 Expires: 2021-10-21

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Quality Engineer

Kelly Services
Gaithersburg, MD 20898

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