- Manages and oversees Quality Engineering activities and develops an engineering team with the skills required to meet product specifications and company procedures.
- Manages department budget by planning expenditures and monitoring spending patterns to ensure they align with company goals.
- Ensures that team is aligned/deployed with the intent of accomplishing departmental key performance indicators (KPI's) and makes immediate/effective adjustments to achieve targets.
- Oversees and participates in MRB, Manufacturing, and Supplier Quality activities, as required to meet overall corporate initiatives.
- Collaborates with various departments to assure timely resolution and provide pragmatic solutions to quality challenges and areas for improvement supporting business Quality and Regulatory needs.
- In collaboration with Manufacturing, Product Reliability, Design and Sustaining Engineering develop Process Improvement initiatives to improve operational & quality performance (i.e., cycle time, backlog, efficiency, yield & defect trending) supporting company strategic objectives.
- Drives product and process improvements based on corrective and preventative actions (CAPA) and supplier corrective actions.
- Analyzes and prepares quality reports and presentations for Management Review.
- Reviews manufacturing product quality trends to determine areas for improvement, and implementation in a timely manner
- Support the Nonconformance Quality Improvement Team (NCQIT) Chair at meetings to analyze trending of nonconformance data. Analysis of data and reporting to Management
- Chairs Supplier Quality Non Conformance Review Board Chair at meetings to analyze trending of nonconformance data. Review and approval of Supplier Initial Evaluation Request Form (SIERF) supplier change notifications (SPCN) and engineering change orders (ECO)
- Improves and/or develops processes and procedures to support Business and the Quality System Objectives.
- Trains employees on quality assurance procedures and processes
- Oversees other projects as assigned
- Bachelor's degree or equivalent experience
- Strong working knowledge of medical device manufacturing requirements, FDA 21CFR820 and ISO 13485, for class III implantable devices, MDSAP and EUMDR
- Strong working knowledge of sterile devices and processes
- Knowledge leader in statistical analysis, FMEA, Risk Management, CAPA, Nonconformance reporting and disposition, Root Cause Analysis and investigations
- Ability to make consistent decision based upon defined requirements and apply common sense understanding to carry out instructions.
- Ability to read and follow and create documents such as procedures, work instructions, inspection instructions, technical specifications and literature.
- Able to work with minimum supervision. Must be detailed oriented and capable of screening for errors in documentation and part anomalies.
- Ability to communicate effectively with co-workers, other area leads, and department management in both written and verbal form.
- Critical-thinking skillset
- Effective organizational and time management skills.
- Strong problem solving skills with ability to drive solutions.
- Must be proficient in the use of personal computer and business/technical software (i.e., Word, Access, Excel, PowerPoint).
- Strong interpersonal skills to work within the team and cross-functionally in the organization.
- Ability to effectively communicate, verbally and in writing, technical issues to/from inspection personnel and customers of inspection services, including suppliers to Advanced Bionics.
- Experienced in working with 3rd Party auditor (Regulatory entities and Notified bodies)
- Lead by example to motivate team members including conflict management, strong decision-making ability & Emotional Intelligence.
- Strong team-oriented, professional with good interpersonal skills and the ability to supervise various functional areas.
- Demonstrated supervisor and/or leadership experience
- Ability to manage QE support for all AB manufacturing, raw materials and Inspection activities
- Clear understanding of regulatory requirements from process control, material traceability, raw material and supplier controls
- Expert knowledge in process and product qualification, verification and validation activities and methodologies (comparative studies IQ, OQ, PQ)
- Experienced in working with 3rd Party auditors (Regulatory entities and Notified bodies)
- Experienced in field action, recalls and remediation efforts
- IPC-610 certified
- ISO 13485 Lead Auditor certification
- Lean six sigma certification
- English/ Proficient
- Familiar with Microsoft programs and other basic computer applications.
- SAP ERP, Camstar, Word, Access, Excel, PowerPoint, Visio, Minitab etc.)
- Exciting and challenging work environment
- Comprehensive benefits package
- Training and development opportunities - we believe every employee deserves a development plan. Come, learn, and grow with us
- Medical, dental and vision coverage
- Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
- TeleHealth options
- 401k plan with company match
- Company paid life/ad&d insurance
- Additional supplemental life/ad&d coverage available
- Short/Long-Term Disability coverage (STD/LTD)
- STD LTD Buy-ups available
- Accident/Hospital Indemnity coverage
- Legal/ID Theft Assistance
- PTO & paid holidays
- Employee Assistance Program
- Plan rules/offerings dependent upon group Company/location.
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Senior Manager, Quality Assurance Operations - Santa Clarita, United States - Sonova
Description
OverviewThis is a leadership role focused Quality Engineering support and management.
This position will oversee quality engineers supporting the following departments receiving inspection, Manufacturing Quality, and Supplier Quality, to assure consistent quality of product by developing and enforcing good manufacturing practices (cGMP), acceptance activities across multiple operations compliant to product specifications and company procedures.
This position will have direct reports: including specialists and engineers. Demonstrated supervisory experience is required, as well as strong engineering skills and experience.What you'll do:
What you bring to the team:
Education
* - 5 years experience in a quality engineering management role.
Our offer:
We love to work with great people and strongly believe that a diverse team makes us better.
We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.
We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Senior Manager, Human Resources.Pay Ranges:
$ 116,800/yr - $175,200/yr
Based on location
Health Benefits & Perks:
We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place.
We guaranteeevery person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.
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