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We are looking for a Sr Quality Manager to join our client in Dover, NH on a direct hire basis.
The Sr. Quality Manager is responsible for developing, establishing and maintaining quality programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. This role will provide Quality Engineering management and leadership for our Dover, NH Manufacturing Plant and our Lansdale, PA distribution facility ensuring compliance with OSHA, FDA, ISO and other relevant standards.
- Provides Quality Systems guidance, training, management and leadership to organization.
- Establishes, documents and implements effective Process Control & Monitoring systems.
- Applies engineering evaluation and experimentation expertise to ensure continuous improvement in product and process capability.
- Manages quality audits and analyzes findings, recommending modifications in products or standards. Identifies opportunities and leads the implementation for system compliance improvement.
- Identifies Quality Initiatives and leads cross-functional teams to complete them.
- Applies sound, systematic problem-solving methodologies in resolving quality issues.
- Utilizes Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in regulation compliance, device, process, and system quality, and cost reductions.
- Is an effective member of the Leadership Team, fostering continuous quality compliance and improvement.
- Maintains effective Quality Metrics and defines and executes activities to resolve decreases in performance.
- Establishes and monitors production standards, examining samples of raw product or directing testing during processing, to ensure finished products are of prescribed quality.
- Formulates sampling procedures and designs, and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Responsible for product labeling compliance and for insuring product specifications are current.
- Investigates customer complaints. Reduces risk through effective system design, implementation and maintenance.
- Ensures continuous improvement with suppliers, components, raw materials, packaging, work-in process (WIP), finished product and equipment.
- Supervises and manages subordinate reports as assigned. Assesses resource requirements to maintain quality support, ensuring that employee competencies are appropriate.
Education and Experience:
- Bachelor’s degree in Engineering or related field.
- Minimum of 7 years of experience in Quality, preferably in Medical Device Manufacturing.
- Knowledge of sterility requirements.
- Six Sigma Black Belt and ASQ Certified.
Knowledge, Skills and Abilities:
- Superior leadership and management skills.
- Documentation skills including ability to read and interpret documents such as safety rules, operating and maintenance instructions, drawings and procedure manuals.
- Problem solving and decision-making skills.
- Must have excellent interpersonal skills and the ability to interface and influence internal and external customers.
- Must have excellent verbal, written and presentation skills.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
- Must have an ability to work without direct supervision and efficiently manage workload, tasks and time.
- Strong computer literacy (Microsoft Word, Excel, Outlook)
- Must possess a strong attention to detail and be a team player
- Expert knowledge of GMP, ISO, standard inspection methods and SPC.
- Demonstrated success in process improvement, product and process qualification and validation, Process Control & Monitoring (SPC).
- Demonstrated success in nonconformance management and reduction, value improvement, risk reduction, and cost containment is required.
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