Senior quality manager job description

Job Title
Senior Manager, Quality Operations - Device

Requisition

JR000012516 Senior Manager, Quality Operations - Device (Open)

Location

Field Based Location - USA082

Additional Locations

Job Description

SummaryThe Senior Manager, Quality Operations is responsible for assuring the overall quality and compliance of products designed and manufactured by or for the Mallinckrodt - Specialty Brands organization. The Sr. Manager, Quality Operations assures that work conducted to design or change the design of products is conducted in a compliant manner that yields a product that is safe and reliable. Works closely with Operations/Manufacturing and Global Device Engineering to support new product development and improve product design. Conducts sound investigations of potential product failures in support of the complaint and CAPA processes. The Sr. Manager will ensure that decisions are made taking into consideration the right risk level and is also responsible to communicate to management situations affecting the safety of the product or pose a compliance risk. Exercises sound decisions in assuring compliance to regulations, practices and policies. Interprets regulations and maintains an awareness of industry trends on compliance issues. Ensure effective relationship management of third party CMO's and internal stakeholders to ensure effective and sustained compliance and product quality improvement.Essential FunctionsExercises sound decisions in assuring compliance by internal functions and Contract Manufacturers to regulations, practices and policies on device related development and post launch activities for products.Establishes and maintains the Quality Engineering function to ensure an efficient pre and post production quality assurance program, from design and development through manufacture and release of medical devices.Balances the need for technical insight whilst ensuring CMO ownership and execution of assigned tasks and responsibilities.Lead design/development change control activities in accordance with all applicable SOPs. Assures the content of design file documents meet regulatory and company requirements. Assure process maps, control plans, design verification and design validation activities are complete, statistically sound and compatible with the risk of the operation and device.Provides oversight of and is the key quality contact with contract manufacturers.Lead Investigations of potential product failures in support of the complaint and CAPA processes. Assure that work is conducted in a sound, scientific manner and documented using compliant practices. Utilize applicable quality engineering and six sigma tools as part of the process.Escalation of all applicable product and product issues to senior leadership through the appropriate escalation processes. Conducts Risk Management activities such as FMEA, HACCP, FTA, etc. as required.Directs manufacturing process validation and assures processes are verified, validated and implemented.Supports inspections and audits by external bodies of Mallinckrodt - Specialty Brands and contract manufacturers.Subject matter expert for the Quality function for the products that are supported.Develops and manages metrics for product reviews, quality management reviews, contract manufacturer oversight and other quality data in support of management and the CAPA system.Approves qualification of material and component suppliers and supports all quality management functions.Lead strategic quality efforts for projects identified by the business unit/region Lead/Host regulatory inspection and respond to inspection observations Support and/or lead product launch activities Perform activities as directed by the Sr. Director of External Manufacturing QualityMinimum RequirementsEducation / Experience / Skills:Bachelor's degree in Engineering or Science required. Prefer Masters within Engineering/ Engineering Management or Science discipline or equivalent experience. Minimum seven (7) years as a Quality Engineer/Manager in the Medical Device industry.Excellent communication skills, self-motivated, a demonstrated ability to lead, and proven effectiveness interacting and coaching team members Demonstrated experience with Design Control, Process Validation, Failure Investigations, Root Cause Analysis and the application of statistics to the practice of Quality Assurance.Must have demonstrable creative problem solving and project management skills Experience leading risk assessments inclusive of FMEA, FTA, HACCP or other risk activities.Good understanding of process, internal and external audits Basic knowledge of statistical techniques, acceptance sampling, and SPCThorough knowledge of Medical Device Regulations - US and Europe - inclusive of Quality System Requirements, ISO 13485, ISO 14971, and Process ValidationAbility to travel up to 20% of the time Deep understanding of quality improvement tools and statistical decision making methods This managerial role is expected to be “hands on” and “working” manager. The manager, within discretion will be expected to execute work activities indicative of a direct report work activities.Preferred Skills/QualificationsDemonstrated experience in improvement business process related to the design and manufacture of Medical DevicesExperience in the Pharmaceutical manufacturing industry Knowledge of reliability engineering Basic knowledge of sterilization techniques and validation Certification as a CQE, Manager of Quality, Six Sigma black belt Experience being part of inspections (FDA, Certified Body) Experience leading process / supplier audits Other Skills / Competencies:Demonstrated commitment to excellent customer service Conflict resolution skills Requires mature judgment in problem solving situations Requires negotiation skills to effectively influence others Ability to identify and drive continuous quality improvement Organizational Relationship/Scope:This position interacts with all levels of the internal organization as well as external CMO partnerships. This position interacts with external regulatory agencies, vendors, suppliers and customers. This position may be required to manage remote/field based company employees.Working Conditions:This position works within a normal and/or remote office environment. This position will travel domestically and internationally, as required. Travel is expected to be 20% on average.

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Quidel's mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We are a leading manufacturer of point of care diagnostic solutions. Quidel's comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.

We are excited to announce that Quidel Corporation is now becoming QuidelOrtho! This transaction will bring together two world-class teams and complementary product portfolios to serve patients around the world. During this transition period, we encourage you to continue visiting our career site and also check out more career opportunities at Careers at Ortho Clinical Diagnostics | Ortho Clinical Diagnostics jobs Join our journey as we become one global diagnostics leader!

This role is responsible for managing one or more quality control departments. Responsible to jointly develop, implement, evaluate, and/or modify on going “best practices” to assure overall operational effectiveness. Directly responsible for overseeing and managing daily quality control operations in support of manufacturing goals and company objective, including setting work schedules, reviewing data trends, and ensuring the adequacy of complex customer complaint investigations involving a variety of laboratory methods, equipment and procedures, oversight of post-market regulatory review, and reporting to the appropriate regulatory bodies for escalated complaints. Position is responsible for assuring product is being assessed efficiently, cost effectively and according to production schedule. Position is responsible for following and assuring team compliance to all GMP's, safety, manufacturing and quality system procedures directly related to the manufacturing process.
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ESSENTIAL FUNCTIONS:Responsible for the day to day managing and direction of the QC testing, QC Analyst and Product Support departments Manages the processing and investigation of complex customer complaints and to provide guidance in the determination root cause(s) Reviews trending reports and analysis of complaint data for presentation to internal and external stakeholders Ensures accurate documentation of the complaint evaluation and investigation results within assigned complaint records Coaches product support staff on techniques for complex investigations including data collection, summary, analysis, and reports Reviews and conduct escalated investigations from complaints including analysis of Quality System documents and process, and acts as final review for complex customer complaint investigations Conducts reviews of complaints escalated for regulatory review and generates/submits reports to appropriate notified bodies Participates in internal and 3rd Party Audits from regulatory bodies including but not limited to the FDA, notified bodies and business partners Assists in developing quality systems & makes recommendations for improvements to existing Quality systems Responsible for meeting production schedules, supporting product transfers and validations.Participates in Lean Initiatives and activities Ensures that investigations into product performance are compliant with all required FDA, ISO and other applicable regulatory agency standards and documentation, as well as EHS, HR, Facilities, Housekeeping standards and requirements Monitors internal and external product performance by supporting the development of staff competency in identifying key performance indicators and establishing trending metrics. Establishes and maintains department metrics. Develops and initiates policies and/or procedures for continuous improvement of those metrics Manages department expenses to achieve budget goals Ensures that approved materials are available at all times to support production goals and timelines Act as an SME for QC responsibilities in both external and internal regulatory audits. The role will include direct interaction with auditors when required Responsible for the ongoing FDA/ISO compliant, cost-effective manufacture of specific products or sup-products Responsible for managing the product stability program including performance trending and associated investigational activities Ensures that the test processes are set-up and operating in accordance with established procedures Manages performance of staff towards department and Company goals, including but not limited to Training and coaching supervisory staff on leading a successful department, feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance Carries out duties in compliance with established business policies
Education and ExperienceBachelor's degree in Chemistry, Biology, Engineering, related field or equivalent required Nine years of testing, analysis, compliant investigation or quality control/assurance experience required with five years of experience in a supervisory role in laboratory environment highly preferred
Skills and KnowledgeKnowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDRExperience in working with semi-automated equipment Advanced knowledge of MS Office and software systems used in manufacturing Ability to perform laboratory operations with a high degree of skill, efficiency and professionalism Understanding of manufacturing systems (documentation, compliance, inventory control, production scheduling/controls, etc.).Solid understanding of the product and manufacturing processes Excellent written and verbal communication skills Prior experience with electronic inventory database transactions (i.e. Oracle, JDE, etc.) highly preferred Understands functionality of manufacturing equipment and operating systems Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies.Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Before you apply, please make sure you share Quidel' s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven, focused on execution, and new product oriented. We succeed by being determined, optimistic team players.

Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Why Orthofix? Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun! As an Orthofix employee, you will become an integral part of our culture by continually demonstrating the highest level of integrity and our beliefs while making an impact to our vision “To be a highly respected global orthopedic and spine company that delivers exceptional value to our patients, customers, team members, partners and shareholders."
Senior Quality Manager (Case for Quality)
How you'll make a difference?
This position is responsible for driving strategic direction, coaching and leadership on the global implementation of the Orthofix Lean Quality/Operational Continues Improvement Initiative. The Lean Champion is an experienced Lean Transformation Leader who demonstrates success in driving improvements across business units and incorporates best practices amongst operational Quality and administrative/support functions.

What will be your Duties and Responsibilities?
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Develop, deploy and oversee Company's Case for Quality (CfQ) and continuous improvement program. Train and mentor Orthofix staff through DMAIC methodology application including certification and training.Develop and maintain continuous improvement program dashboards, initiative pipeline and management processes.Communicate with Senior Leadership on program and strategy development across business units.Participate and/or directly lead complex initiatives across business units and operations.Influence change across diverse organization and operational units.Work with and develop vendor/supplier partners to improve Quality, Delivery and Cost. Will include travel to vendor locations and leading kaizen events on their location.

What skills you'll need?
A minimum of 10 years of progressive leadership experience implementing Lean principles and tools, driving change and leading continuous improvement initiatives.Bachelor's degree from an accredited college or university with a preference for a bachelor degree in a technical engineering discipline (e.g. manufacturing, industrial, process, etc.).Quality planning and risk management in an ISO 13485 quality system Strong experience in implementing Lean tools such as Hoshin Kanri, A3, 5's, Standard Work, SMED, TPM, Poka-Yoke, Jidoka, Value Stream Map, Line Balancing, Visual Management, Kanban, Gemba, Heijunka, etc.Root cause analysis, problem solving and corrective and preventive action as they related to complaints, non-conforming material, post-market surveillance or other quality data Hands-on experience in converting a traditional operation (service or manufacturing) to a Lean Manufacturing Operation with a disciplined focus on customer satisfaction.Ability to implement change at all levels of the organization and to drive projects and requests to completion through other people without having direct supervisory responsibility.Strong change management and influence skills as well as ability to negotiate and communicate at different levels of the organization.Proven problem-solving and negotiation capabilities along with a process-focused perspective.Ability to simplify strategy into simple actions, make decisions effectively, create focus, pursue big ideas, encourage smart experimentation, and bring innovation to the organization.Lean Black Belt certification.Lean Bronze certification.Advance computer skills and working knowledge of Microsoft applications including MS Excel, Power Point and Word.

Non Essential Skills, Experience and Qualifications (not necessary but preferred)
Experience in a medical device manufacturing environment.Lean Master Black Belt Certification.Lean Silver or Gold Certification.Six Sigma Black Belt Certification.

Supervisory Responsibilities
Manage indirectly the Lean Leaders at each location.

Physical Demands and Work Conditions
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 40 lbs.Eyesight and hearing must be correctable to standard level.Domestic and International Travel up to 50%

Orthofix complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Orthofix makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Orthofix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.