Orchid Orthopedics
ABOUT USOrchid Orthopedic Solutions is a contract manufacturer of orthopedic devices that serve to enable a longer and more active life.
Orchid specializes in implants, instruments and innovative technologies for the following markets:
joint reconstruction, spine, trauma, sports medicine, extremities and dental.
Orchid's largest manufacturing facility is located in Bridgeport, MI.
This 85,000 sq ft facility specializes primarily in cutting tools for orthopedic, dental and trauma markets.
Our core products include burs, pins, screws, drills, reamers, and saw blades for both implants and instruments.
A career with Orchid provides training and growth opportunities, a great benefits package, including performance bonuses, insurance, 401(k) with company match, paid time off and employee events.
For more information, please visit www.
orchid-ortho.
comSHIFTNo Shift ($0) (United States of America)The Senior Quality Manager assures compliance and progress towards the established goals of the organization as the quality department head by developing and enforcing quality standards and good business practices.
They communicate and ensure customer expectations and regulation requirements are met.
WHAT YOU WILL DOAchieve business assurance objectives and effective operation of the compliance organization by understanding, communicating, training and enforcing compliance standards, policies and procedures throughout the business.
Add customer value through developing procedures and providing leadership to cross functional teams, formal problem solving (including true root cause analysis), PDCA, statistical analysis to reduce variation, built in quality, etc.
Play a key role in driving improved integration of the production and quality functions.
Contribute information and analysis to strategic plans and reviews; preparing and completing action plans; implementing appropriate countermeasures for KPI's, identifying and resolving problems; completing audits; determining system improvements; implementing change.
Recommend new work methods, layouts, processes and equipment to improve performance.
Achieve quality assurance operational objectives by developing and monitoring appropriate site-specific quality metrics to meet company objectives.
Collaborate with the New Product Introduction team to support engineers focused on analyzing, developing, and implementing quality standards and processes for new product launches at the site, including customer collaboration in the development of APQPs.
Ensures timely reporting and analysis of all customer and internal complaints.
Manage the Corrective and Preventive Action (CAPA) system and ensures timely and effective action is taken and documented.
Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence, determining operational and performance qualification; writing and updating quality assurance procedures.
Facilitate MRB review and disposition of non-conforming product.
Support internal and external audits of the quality systems.
Oversee Quality Control at the site including, in process inspection and measurement, final inspection and measurement, and quality record reviewAssists the development of essential QMS deliverables including, but not limited to:
complaint analysis, risk management, failure mode and effects analysis, CAPA, and process/equipment/software verification/validationEngender a quality culture throughout the business, holding regular briefings with employees to continually champion the Quality cause.
Lead and develop direct reports.
Ensure the company's quality policy is understood and implemented.
Ensure all Health & Safety rules are adhered to and maintain a safe environment.
Identify areas for cost reduction and productivity improvements.
Recommend new work methods, layouts, processes and equipment to improve performance.
EDUCATION QUALIFICATIONSBachelor (Required)Master (Preferred)EXPERIENCE QUALIFICATIONS8
Years of Experience in Quality (Required)5
Years of Experience in Leadership (Required)3
Years of Experience in a Leadership Position in a Manufacturing Environment (Preferred)10
Years of experience in Quality (Preferred)LICENSES AND CERTIFICATIONSCertified Manager of Quality/Organizational Excellence (CMQ/OE) - American Society for Quality (ASQ) (Preferred)KNOWLEDGE & SKILLS THAT ENABLE SUCCESSAccuracy and Attention to Detail - Extensive ExperienceChange Leadership - Extensive ExperienceCommunication - Working ExperienceCustomer Communication - Working ExperienceComputer Knowledge - Working ExperienceData Analysis Tools - Extensive ExperienceDecision Making and Critical Thinking - Working ExperienceInspection Knowledge - Extensive ExperienceManufacturing Industry - Working ExperienceOrganization - Working ExperiencePower BI - Basic KnowledgeStandard Operating Procedures - Extensive ExperienceLeadership - Working ExperienceProblem Solving - Working ExperiencePHYSICAL DEMANDSMust be able to remain in a stationary position - FrequentlyMust be able to move about the inside of the building - OccasionallyMust be able to communicate and exchange information with others - ConstantlyMust be able to distinguish and detect information such as writing and defects - ConstantlyApplicants must be authorized to work for ANY employer in the U.
S.
We are unable to sponsor or take over sponsorship of an employment Visa at this time.
WHAT WE OFFEROpportunity to work in a growing companyAbility to help people live a longer, more active lifeComprehensive benefit packageAbility to work in an organization that values:
Integrity First:
We do the right thingTeamwork:
We are one OrchidResults:
Our results matterADDITIONAL REQUIREMENTSCandidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirementsCandidates must be able to provide proof of eligibility to work in the United States through eVerifyEOE, including disability/vetsOrchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.
About the Company:
Orchid OrthopedicsOrchid is a worldwide leader of orthopedic medical device outsourcing, providing contract design and manufacturing services.
We are a strategic sourcing partner that can handle an entire project or provide services at a Single Point in the process.
We have the broadest portfolio in the industry, ranging from design and development through finished goods manufacturing and packaging, and we improve our customers' supply chains through our supply chain solutions.
Orchid specializes in implants, instruments and innovative technologies for the following markets:
Joint reconstructionSpineTraumaSports MedicineExtremitiesDentalWe are driven to success through our customer-focused team, living out our core purpose and values and striving for continuous improvement.
Company Size:
20 to 49 employeesIndustry:
Manufacturing - OtherFounded:
2011.
Estimated Salary: $20 to $28 per hour based on qualifications.
Orchid specializes in implants, instruments and innovative technologies for the following markets:
joint reconstruction, spine, trauma, sports medicine, extremities and dental.
Orchid's largest manufacturing facility is located in Bridgeport, MI.
This 85,000 sq ft facility specializes primarily in cutting tools for orthopedic, dental and trauma markets.
Our core products include burs, pins, screws, drills, reamers, and saw blades for both implants and instruments.
A career with Orchid provides training and growth opportunities, a great benefits package, including performance bonuses, insurance, 401(k) with company match, paid time off and employee events.
For more information, please visit www.
orchid-ortho.
comSHIFTNo Shift ($0) (United States of America)The Senior Quality Manager assures compliance and progress towards the established goals of the organization as the quality department head by developing and enforcing quality standards and good business practices.
They communicate and ensure customer expectations and regulation requirements are met.
WHAT YOU WILL DOAchieve business assurance objectives and effective operation of the compliance organization by understanding, communicating, training and enforcing compliance standards, policies and procedures throughout the business.
Add customer value through developing procedures and providing leadership to cross functional teams, formal problem solving (including true root cause analysis), PDCA, statistical analysis to reduce variation, built in quality, etc.
Play a key role in driving improved integration of the production and quality functions.
Contribute information and analysis to strategic plans and reviews; preparing and completing action plans; implementing appropriate countermeasures for KPI's, identifying and resolving problems; completing audits; determining system improvements; implementing change.
Recommend new work methods, layouts, processes and equipment to improve performance.
Achieve quality assurance operational objectives by developing and monitoring appropriate site-specific quality metrics to meet company objectives.
Collaborate with the New Product Introduction team to support engineers focused on analyzing, developing, and implementing quality standards and processes for new product launches at the site, including customer collaboration in the development of APQPs.
Ensures timely reporting and analysis of all customer and internal complaints.
Manage the Corrective and Preventive Action (CAPA) system and ensures timely and effective action is taken and documented.
Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence, determining operational and performance qualification; writing and updating quality assurance procedures.
Facilitate MRB review and disposition of non-conforming product.
Support internal and external audits of the quality systems.
Oversee Quality Control at the site including, in process inspection and measurement, final inspection and measurement, and quality record reviewAssists the development of essential QMS deliverables including, but not limited to:
complaint analysis, risk management, failure mode and effects analysis, CAPA, and process/equipment/software verification/validationEngender a quality culture throughout the business, holding regular briefings with employees to continually champion the Quality cause.
Lead and develop direct reports.
Ensure the company's quality policy is understood and implemented.
Ensure all Health & Safety rules are adhered to and maintain a safe environment.
Identify areas for cost reduction and productivity improvements.
Recommend new work methods, layouts, processes and equipment to improve performance.
EDUCATION QUALIFICATIONSBachelor (Required)Master (Preferred)EXPERIENCE QUALIFICATIONS8
Years of Experience in Quality (Required)5
Years of Experience in Leadership (Required)3
Years of Experience in a Leadership Position in a Manufacturing Environment (Preferred)10
Years of experience in Quality (Preferred)LICENSES AND CERTIFICATIONSCertified Manager of Quality/Organizational Excellence (CMQ/OE) - American Society for Quality (ASQ) (Preferred)KNOWLEDGE & SKILLS THAT ENABLE SUCCESSAccuracy and Attention to Detail - Extensive ExperienceChange Leadership - Extensive ExperienceCommunication - Working ExperienceCustomer Communication - Working ExperienceComputer Knowledge - Working ExperienceData Analysis Tools - Extensive ExperienceDecision Making and Critical Thinking - Working ExperienceInspection Knowledge - Extensive ExperienceManufacturing Industry - Working ExperienceOrganization - Working ExperiencePower BI - Basic KnowledgeStandard Operating Procedures - Extensive ExperienceLeadership - Working ExperienceProblem Solving - Working ExperiencePHYSICAL DEMANDSMust be able to remain in a stationary position - FrequentlyMust be able to move about the inside of the building - OccasionallyMust be able to communicate and exchange information with others - ConstantlyMust be able to distinguish and detect information such as writing and defects - ConstantlyApplicants must be authorized to work for ANY employer in the U.
S.
We are unable to sponsor or take over sponsorship of an employment Visa at this time.
WHAT WE OFFEROpportunity to work in a growing companyAbility to help people live a longer, more active lifeComprehensive benefit packageAbility to work in an organization that values:
Integrity First:
We do the right thingTeamwork:
We are one OrchidResults:
Our results matterADDITIONAL REQUIREMENTSCandidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirementsCandidates must be able to provide proof of eligibility to work in the United States through eVerifyEOE, including disability/vetsOrchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.
About the Company:
Orchid OrthopedicsOrchid is a worldwide leader of orthopedic medical device outsourcing, providing contract design and manufacturing services.
We are a strategic sourcing partner that can handle an entire project or provide services at a Single Point in the process.
We have the broadest portfolio in the industry, ranging from design and development through finished goods manufacturing and packaging, and we improve our customers' supply chains through our supply chain solutions.
Orchid specializes in implants, instruments and innovative technologies for the following markets:
Joint reconstructionSpineTraumaSports MedicineExtremitiesDentalWe are driven to success through our customer-focused team, living out our core purpose and values and striving for continuous improvement.
Company Size:
20 to 49 employeesIndustry:
Manufacturing - OtherFounded:
2011.
Estimated Salary: $20 to $28 per hour based on qualifications.
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