Quality Engineer

Straumann Group; Andover (MA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

401(k) match

Health, dental and vision insurance

Generous PTO

Job summary

Straumann Group is seeking a Quality Systems professional to support validation, quality compliance, and risk management across multiple sites in the U.S. You will develop and enforce local QMS processes to meet ISO and FDA requirements, and you will validate equipment and processes from early production stages.

The role involves planning and reporting validations, participating in audits, and driving improvement through CAPA and change management.

Qualifications

• Bachelor's degree in quality, engineering and/or manufacturing fields preferred.
• 3+ years quality control or quality assurance experience in the medical device manufacturing field.
• Familiarity with US and International medical device regulations and registrations.
• Experience with planning, execution and reporting of equipment and process validations.
• Excellent written communication skills.

Responsibilities

• Plans, executes, and reports on equipment and process validation.
• Assists with training on quality and compliance concepts and best practices.
• Work with Quality team and cross-functional teams to conduct quality investigations, identify root causes, and present potential solutions.
• Supports Treatment Planning teams in planning and execution of audits by external partners, regulatory authorities and/or their representatives.
• Creates and maintains the Risk Management program and works with internal team on risk mitigation strategies.
• Creates and maintains the change management program.
• Participates in the development, implementation, and reporting of metrics of interest to local operations, management, and external partners.

Skills

Quality principles

Root cause analysis

CAPA

FMEA

Documentation

Quality systems

Microsoft Office

Education

Bachelor's degree in quality, engineering and/or manufacturing fields preferred

Tools

IQ/OQ/PQ protocols

CAPA system

Risk Management software

Job description

Summary of Position Supports and implements systems in the areas of validation, advanced quality, risk management, change control, and design and development. Supports the development and enforcement of internal systems and procedures to meet the local Quality Management System, ISO standards, FDA quality system regulation, and other regulatory requirements. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process. Specifies and implements new inspection equipment and instructs others in its proper use

Essential Functions And Duties

• Plans, executes, and reports on equipment and process validation.
• Assists with training on quality and compliance concepts and best practices.
• Work with Quality team and cross-functional teams to conduct quality investigations, identify root causes, and present potential solutions.
• Supports Treatment Planning teams in planning and execution of audits by external partners, regulatory authorities and/or their representatives.
• Creates and maintains the Risk Management program and works with internal team on risk mitigation strategies.
• Creates and maintains the change management program.
• Participates in the development, implementation, and reporting of metrics of interest to local operations, management, and external partners.
• Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area.
• Accurately records and reports of information as required.
• Follows employee policy within the company.

Non-essential Functions And Duties

• Attends Quality and other meetings as required
• Participates in additional training relevant to this position.
• Other duties may be assigned, directed or requested

Qualifications

• Must be proficient in English spoken and written language
• Bachelor's degree in quality, engineering and/or manufacturing fields preferred.
• Must have 3+ years quality control or quality assurance experience in the medical device manufacturing field
• Ability to work with multidisciplinary teams across multiple countries to execute projects, investigations, and training.
• Demonstrated ability to plan and work to robust timelines
• Experience in planning, execution and reporting of equipment and process validations
• Excellent understanding of quality principles and good documentation practices
• Familiarity with US and International medical device regulations and registrations.
• Must be familiar with, and competent in, conducting and managing Risk Management plans and summaries. Familiarity with ISO 13485 preferred.
• Knowledge of design control processes.
• Experience with managing non-conformances and CAPA.
• Front and back room audit experience.
• Must be able to utilize basic quality tools including RCA, Fishbone analysis, SPCs, FMEA, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts.
• Must be able to produce technical documents, testing and validation plans, IQ/OQ/PQ protocols and formal procedures.
• Six Sigma/Lean Manufacturing skills preferred.
• Must have excellent written communication skills
• Must have basic computer skills (Microsoft Office).

Key Attributes Straumann Group has been inspired to make people’s lives better, improve oral health and restore people’s self-esteem and driving the company’s purpose to unlock the potential of people’s lives. Culture has always been the foundation of our success, guided by our beliefs: customer obsession, entrepreneurial mindset, agility & decisiveness, ownership, passion for learning, psychological safety, and driving engagement.

Additional Qualities Of The Successful Candidate Include The Following

• Resourceful and Hands-on: An energetic, resourceful, agile, and hands-on individual who operates effectively with minimum direction and pursues objectives and works to deliver against goals relentlessly; able to get to the heart of issues rapidly and act decisively
• Team Player: From a basis of strong self-awareness, excellent interpersonal skills; fosters team-first mentality and shares wins and successes; creates an open and transparent environment in which individuals can team together to drive optimal outcomes
• Results-driven: Brings a fire in the belly and is counted on to meet or exceed commitments on time, every time; has a genuine passion for patient outcomes and quality
• Collaborative Relationship-builder: Able to build deep relationships with key internal and external stakeholders, and work closely with/ and earn the respect and trust of other teams
• Integrity: Possesses unquestionable integrity and is intellectually curious; is known as an honest, trustworthy, ethical, and straightforward individual, capable of presenting the unvarnished truth in an appropriate and helpful manner
• Straumann Group prides itself on employee’s embracing the player/learner mindset that embodies a high-performance culture and learning organization

Work Environment

• Work is performed in an office environment (50%)
• Work is performed in an manufacturing environment (50%)
• The employee may occasionally be exposed to dust
• The noise level in the work environment is usually quiet to moderate
• Will work in a fast-paced, team environment

Salary: $80,000 - $110,000/ Annually.

Additional Information

• Very Competitive total compensation plans (some positions include discretionary bonus, or Performance Share Units).
• A 401(K) plan to help you plan for your future with an employer match
• Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy. Straumann contributes a healthy portion towards employees’ premium.
• Generous PTO allowance - plenty of time to recharge those batteries!

Videos To Watch

https://youtu.be/3lq5BLAvIdQ

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type: Full Time

Alternative Locations: United States : Andover (MA)

Travel Percentage: 0%

Requisition ID: 22007

22007