Quality Assurance Manager - New Product Devel

Job purpose

As a member of the Quality Department, the Quality Assurance Manager – New Product Development will oversee a team of quality engineers. Support the product development process / teams through the product realization process including design control and risk management. Support the Quality Management System (QMS) by ensuring processes are documented, updating QA leadership on the effects of the QMS and areas for improvement, and promote quality policies throughout the organization. Partner with R&D and Regulatory teams to ensure procedures are compliant and accurately documented for submissions.

Duties and responsibilities

• Work with the R&D teams to ensure new product design projects are executed per internal and external Regulatory requirements and Endotronix design control and risk management procedures
• Generate Quality Plans to support compliant development and commercialization of new products including the development of acceptance criteria, quality test methods, reliability analysis, risk management plans (ensure field data is considered for new product design), DHF audits, etc.
• Partner with R&D to create design and development plans with adequate phase and design control gates including DHF audits and design reviews.
• Support the Quality Management System (QMS) Management Representative by:
  • Ensure the processes needed for the quality management system are documented.
  • Report to top management on the effects of the QMS and any need for improvement.
  • Ensure the promotion and awareness of applicable regulatory requirements and QMS requirements throughout the organization
• Partner with R&D to ensure efficient and compliant Quality System procedures for Product Development, Life Cycle Management and Software Quality are established
• In partnership with R&D, ensure compliance with the most current ISO 14971, through design transfer
• Ensure all quality and regulatory-driven requirements for all products and services, in all intended markets, are mapped into product specifications and are traceable.
• Write / review protocols and reports, FMEAs, Design Verification & Validation, Control Plans, Software development strategies, plans and reports, Process Validation protocols and reports.
• Provide input into the development of the DHF, inspection plans and quality test method validations, quality agreements, process control plans and supplier agreements, with a key emphasis on Design Transfer
• Support Failure Analysis by collaborating with Quality, Engineering, and Manufacturing on investigations.
• Lead and/or support CAPA and NCR investigations
• Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
• Define and monitor Product Development metrics to drive product and process improvements
• Leads cross functional team on how to document changes, using a risk-based approach for determining requirements.
• Effectively communicate progress, consistently driving solutions where necessary. Escalate issues requiring attention in a timely manner and with a sense of urgency
• Manage and develop Quality Engineering – New Product Development resources

Qualifications

• 5+ years in a Product Quality, Quality Engineering, technical or engineering field with at least 2 years in the medical device industry
• 2+ years in a Managerial role
• Direct experience with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 compliance (EU MDR experience a plus)
• Experience with the development, validation, and manufacture of medical devices
• Strong writing, mathematics and statistics skills
• Demonstrated ability to work well within a fast paced, dynamic team environment
• Ability to negotiate and influence key stakeholders to ensure compliance with regulatory requirements and business needs

Education

Key Leadership & Behavioral Competencies

• Leadership - Creates a vision for a company, function or department that defines a high level of expectation and standard of performance. Ability to see beyond today’s constraint to understand tomorrow’s possibility. Has the ability to engage others to follow and can persuade others to a common Course of action. Creates an environment that promotes others to learn, excel and strive for Maximum performance and is characterized by: Commitment to success, definition of priorities, a demand for high standards of excellence, being tough and fair, concentrating on the positive, having a strong sense of urgency, not being afraid to fail and encourages calculated risk.
• Management -
  • Set Objectives- Tell people what you expect them to do.
  • Allocate Resources- Organize the work for capacity and tools.
  • Motivates and communicates- Tell people why the effort is important and listen to feedback
  • Measure & Control- Active looking at information and feeding it back to the individual. Make sure the work is done and tell them what the measure is.
• Develop People- Help the people who work for us to do better and do more. Share with everyone how it fits with the organization.
• Respect for the individual - Treats others as you expect to be treated, encourages diversity and strives to have the workforce mirror our customers, appreciates candor and clear and specific communication to express concerns and expectations, characterized by integrity, dependability, empathy, and honesty, Provides for recognition of contributions to the organization and society, seeking first to understand the others point of view then seeking to be understood.
• Innovation and Continuous Improvement - Commitment to continuous learning and implementation of better methods, tools and practices to increase customer employee and stockholder satisfaction. A clear understanding of Gaps in the organization learned through facts or data gathered & analyzed followed by a clear action plan to reduce the gaps through learning and training. By constantly striving to innovate and improve processes by reducing “waste or Noise” in the system, we believe we will have the ability to stay ahead of our competition in the marketplace.
• Customer Focus - Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
• Operate within Ethical, Moral, & Regulatory Standards -Continuously demonstrates in actions and speech the highest level of commitment to honesty, transparency, and ethical behavior and compliance with all applicable laws and regulations

• Business Acumen – Knows how businesses work; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
• Problem Solving - Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.
• Dealing with Ambiguity – Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty.
• Strategic Agility - Sees ahead clearly; can anticipate future consequences and trends accurately; has broad knowledge and perspective; is future oriented; can articulately paint credible pictures and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans.
• Managing Through Systems - Can design practices, processes, and procedures which allow managing from a distance; is comfortable letting things manage themselves without intervening; can make things work through others without being there; can impact people and results remotely.
• Drive for Results - Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.

Personal Characteristics

• Willing to have the “direct and honest conversation”. Not afraid to confront the facts (or be confronted) and develop a plan to move forward.
• Competitive spirit and drive to win. Strong sense of initiative, internal motivation and an unrelenting focus on results.
• Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.
• Capacity to function in a highly complex, company with ease and fluidity, while driving and influencing results.
• Entrepreneurial, flexible, yet results-focused.
• High degree of intellectual curiosity, honesty and capability.
• Low ego and humble in spirit in spite of his/her track record of outstanding performance.

Position Type / Expected Hours of Work

Full Time. Salary Exempt

Working conditions

This job operates in a professional office environment. This role routinely uses standard office equipment.

Physical Requirements

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

EEO Statement