Quality Engineer - Flower Mound, United States - FFF Enterprises

Description

Job DetailsJob LocationFlower Mound, TXRemote TypeHybridSalary Range$80, $125,000.00 SalaryDescriptionPosition SummaryThe Quality Engineer is a key subject matter expert on supplier quality and quality engineering.

The Quality Engineer will develop, implement, and lead supplier and production standards for a company's process and products by establishing quality systems and setting product requirement rules.

Duties include identifying the specifications requirements, determining an appropriate level of variation and monitoring quality assurance rates as well as supplier management.

Essential Functions and DutiesOversee the management and coordination of the supplier management process for Operations and RightNow Inventory. Including supplier evaluations, onboarding, approved supplier list, supplier audits, ongoing re-evaluation, and scorecards.
Assist with the creation and review, with input for Quality Management and Contracts, of Quality Agreements.

Support product quality and manufacturing activities and are accountable for driving change, establishing effective and sustainable business processes (nonconformity, customer complaints and CAPA), improving product quality, and providing senior management with actionable data mining/analysis and status updates.

Contribute and lead risk management processes including Design Failure Mode and Effects Analysis (DFMEA), ProcessFailure ModeEffects Analysis(PFMEA) and GAP Analysis.

Review and approve design phase plans to ensure outputs equals inputs.

Develop, implement, and oversee a quality inspection planning process, both internal and for suppliers including incoming and outgoing materials and products.

Provide SME input regarding calibration monitoring and maintenance in adherence with ISO 17025.Review, approve and support supplier process validations and software validations.

Evaluate, review, and approve change control requests for products, software, and processes.
Ensures a high standard of performance and conformance to Quality Management Systems.
Continuously strive to improve processes, service quality to internal and external customers. Adheres specifically to all company policies and procedures, Federal and State regulations, and laws.
Display dedication to position responsibilities and achieve assigned goals and objectives.
Always represent the Company in a professional manner and appearance.
Understand and internalize the Company's purpose, Display loyalty to the Company and its organizational values.
Display enthusiasm and dedication to learning how to be more effective on the job and share knowledge with others.

Work effectively with co-workers, internal and external customers and others by sharing ideas in a constructive and positive manner; listen to and objectively consider ideas and suggestions from others; keep commitments; keep others informed of work progress, timetables, and issues; address problems and issues constructively to find mutually acceptable and practical business solutions; address others by name, title, or other respectful identifier, and respect the diversity of our work force in actions, words, and deeds.

Comply with the policies and procedures stated in the Injury and Illness Prevention Program by always working in a safe manner and immediately reporting any injury, safety hazard, or program violation.

Ensure conduct is consistent with all Compliance Program Policies and procedures when engaging in any activity on behalf of the company.

Immediately report any concerns or violations.
Other duties as assigned.

QualificationsEducation, Knowledge, Skills, and ExperienceRequired Education:
Bachelor's degree in engineering or another STEAM field; or four (4) years relevant experience in lieu of degree

Required Knowledge:
Comprehensive understanding of the quality system regulations, cGMP and ISO standards

Required Experience:

Must have at least three (3) years [seven (7) for non-degreed candidates] of experience in quality engineering or engineering within the medical device or pharmaceutical field.

Experience in the areas of risk assessment, calibration, change control, non-conformances and supplier management and sampling plans.


Required Skills:
Effective team member, motivated to achieve and demonstrate best practices in line with the department and global objectives.
Must have excellent analytical and problem-solving skills.
Must have a detail orientation and the proven ability to prioritize work.
Must have effective verbal and written communication skills.
Must have the ability to work with limited supervision and as part of a team.
Sound decision-making abilities.
Excellent communication skills with the ability to influence others.
Must have strong organizational skills.
Demonstrated ability to follow detailed SOPs and utilize good documentation practices.
Physical requirementsVision, hearing, speech, movements requiring the use of wrists, hands and/or fingers.

Must have the ability to view a computer screen for prolonged periods and the ability to sit for extended periods.

Must have the ability to work the hours and days required to complete the essential functions of the position, as scheduled.

The employee occasionally lifts to 20 lbs. and occasionally kneels and bends. Must have the ability to travel occasionally. Working condition include normal office setting.
Mental DemandsLearning, thinking, concentration and the ability to work under pressure, particularly during busy times.

Must be able to pay close attention to detail and be able to work as a member of a team to ensure excellent customer service.

Must have the ability to interact effectively with co-workers and customers, and exercise self-control and diplomacy in customer and employee relations' situations.

Must have the ability to exercise discretion as well as appropriate judgments when necessary. Must be proactive in finding solutions.

Direct ReportsNoneEEO/AAP StatementFFF Enterprises/Nufactor is an equal opportunity employer to all and prohibits discrimination and harassment based on the following characteristics:

race, color, caste, religion, religious creed (including religious dress and grooming practices), national origin, ancestry, citizenship, physical or mental disability, medical condition (including cancer and genetic conditions), genetic information, marital status, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender, gender identity, gender expression, age (40 years and over), sexual orientation, veteran or military status, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or any state protected leaves), domestic violence victim status, political affiliation, reproductive health decision-making, and any other characteristic protected by state or federal anti-discrimination law covering employment.

These categories are defined according to Government Code section The Company prohibits unlawful discrimination based on the perception that anyone has any of those characteristics or is associated with a person who has or is perceived as having any of those characteristics.